Atrial Flutter

26

Review clinical trials related to Atrial Flutter. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF. The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.

Participants needed: 50
Trial details
Age: 40-120Biological sex: AllType: ObservationalSponsor: Tulane UniversityUpdated: Jun 15, 2026Locations: 3
Eligibility criteria

Male or female patients age 40 years of age or older [+1]

Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutte... [+12]

Status: Recruiting

Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures

The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: LUMA Vision Ltd.Updated: Jun 10, 2026Locations: 1
Eligibility criteria

IC1: Subject is at least 18 years of age at the time of consent [+3]

EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not fea... [+7]

Status: Recruiting

Anatomical Navigation for Guided Electrophysiology in AFL and AFib

The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: LUMA Vision Ltd.Updated: Jun 10, 2026Locations: 1
Eligibility criteria

IC1: Subject is at least 18 years of age at the time of consent [+3]

EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not fea... [+5]

Status: Recruiting

Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)

The goal of this randomized clinical trial is to learn whether patients with symptomatic atrial fibrillation or atrial flutter (AF) who require heart imaging to rule out a blood clot before cardioversion would benefit from cardiac computed tomography angiography (CCT) in the emergency department (ED) compared to current standard of care management. This will be a multicenter trial evaluating whether CCT-facilitated cardioversion in the ED reduces hospital admission, reduces repeat presentations to hospital and improves patient quality of life compared to the current standard of care. Participants will undergo CCT-facilitated cardioversion or be treated according to current standard of care while in the ED and complete quality of life questionnaires in the ED and follow-up at 30 days.

Participants needed: 190
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ottawa Heart Institute Research CorporationUpdated: Jun 9, 2026Locations: 3
Eligibility criteria

Age ≥18 years old; and [+2]

Patients with an indication for emergency cardioversion (e.g. hemodynamic instab... [+1]

Status: Recruiting

Acute Atrial Fibrillation and Flutter Treated Electively

The AFFELECT -study compares two types of treatment modalities for acute atrial fibrillation or flutter for patients in whom rhythm control is desirable. The main purpose is to observe if these arrhythmias can be safely treated electively (within 5-9 days). All patients are recruited in the emergency department. Patients must be in good clinical condition so that they can be discharged regardless to which treatment modality is randomly selected to them. Patients randomized to conventional care are treated conventionally which means acute rhythm control is applied by electrical or medical cardioversion in the emergency department (within 48 hours of onset of the arrhythmia). Patients randomized to elective care are discharged immediately after adequate temporary rhythm control is assured. All patients will visit a cardiologist out-patient clinic at approximately one week after the emergency room visit. Patients randomized to elective treatment and still in atrial fibrillation or in atrial flutter will be restored to sinus rhythm by electrical or medical cardioversion at the out-patient clinic. Cardiovascular status and treatment options are evaluated for all patients. Anticoagulation is managed according existing guidelines for all patients. Due to possibility of delayed cardioversion in the interventional group (elective care group), all patients receive anticoagulation before the out-patient clinic despite their thromboembolic risk. All patients who have not received adequate anticoagulation for three weeks prior to the delayed cardioversion will undergo a transesophageal cardiac ultrasound to ensure they are not in excess risk for thromboembolic events. Patients randomized to elective treatment have the possibility to opt-out and undergo acute cardioversion if their symptoms are unmanageable during the first week before the out-patient clinical. All patients are monitored for their symptoms by a standardized quality-of-life questionnaire and for possibly required acute medical interventions during the first week and one month after the out-patient clinic. After one month, all patients undergo an electrocardiography (ECG) to ensure the maintenance of normal rhythm in both treatment groups. After the months follow-up all patients are subsequently monitored for a maximum of five years for need of medical interventions due to atrial fibrillation of atrial flutter. New antiarrhythmics such as flecainide are not prescribed during the first month.

Participants needed: 500
Trial details
Biological sex: AllType: InterventionalSponsor: Tampere UniversityUpdated: May 22, 2026Locations: 4
Eligibility criteria

Patients presenting with acute (<48hours) atrial fibrillation or atrial flutter... [+3]

Haemodynamically stable (mean arterial pressure above 60mmHg) [+7]

Status: Not yet recruiting

Home Monitor for AA Burden Detection IIT in TWN

Primary Endpoint: * Early detection rate in Atrial Arrhythmia (AA) burden * Data transmission success rate for overall number of atrial burden collection during the monitoring period Secondary Endpoints: * Atrial burden occurrence at 3/6/12 months post-aATP * Incidence of arrhythmia * Safety: Immediate (\< 24 hours), in-hospital, 3 months, 6 months and 12 months adverse events

Participants needed: 30
Trial details
Age: 20+Biological sex: AllType: ObservationalSponsor: National Taiwan University HospitalUpdated: May 7, 2026Locations: 1
Eligibility criteria

Adult patients ≥ 20 years of age [+4]

Patients are not able to use CardioMessenger 4G or its successors [+9]

Status: Not yet recruiting

Cardiologist-Administered Midazolam vs. Anaesthesiologist-Assisted Propofol Sedation For Transoesophageal Echocardiography-Guided Cardioversion of Atrial Fibrillation

Irregular heart rhythms, known as atrial fibrillation or atrial flutter, are common conditions that can increase the risk of stroke and heart failure. A standard treatment to restore a normal rhythm is a controlled electric shock, known as cardioversion. However, if the irregular rhythm has lasted more than 24 hours, if the duration is uncertain, and if the patient has not been on blood-thinning medication for at least three weeks, doctors must first check for blood clots in the heart. This is done using a special ultrasound scan of the heart through the food pipe. Both the scan and the electric shock treatment require sedation to make the patient relaxed or asleep. The scan uses mild sedation from a cardiologist, while the shock needs a stronger sedative given by an anaesthesiologist. But needing this extra doctor can cause delays, so patients often wait longer for treatment and to go home. This study will test whether a cardiologist can safely handle both steps using a sedative called midazolam. This study will include 220 adults at multiple hospitals in Denmark and compare this new approach to standard care. Researchers will track how quickly patients go home, how well the treatment works, any serious side effects, what patients think about the experience, and how much money can be saved. If proven safe and effective, this new method could reduce treatment delays, shorten hospital stays, and lower healthcare costs-ultimately improving care for patients and making the healthcare system more efficient.

Participants needed: 220
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Gødstrup HospitalUpdated: May 6, 2026Locations: 2
Eligibility criteria

Adult patients (≥18 years) with atrial fibrillation or flutter [+1]

Previous enrolment in the trial [+10]

Status: Not yet recruiting

HeartBeam ECG Registry

The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: HeartBeam, Inc.Updated: Mar 30, 2026Locations: 1Duration: 1 Day
Eligibility criteria

Not listed

Status: Recruiting

Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation

The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices. Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management without the above atrial fibrillation rhythm control treatment. Researchers will compare early rhythm control groups to general control groups to see if early rhythm therapy works to reduce the atrial fibrillation burden by 50% or more, or decrease the incidence of clinical AF documentation. Participants will: * Randomly allocated to two groups at a 1:1 ratio. * Receive the treatment according to their assigned group. * Visit the clinic once every three months for checkups and tests.

Participants needed: 520
Trial details
Age: 19+Biological sex: AllType: InterventionalSponsor: Samsung Medical CenterUpdated: Mar 3, 2026Locations: 1
Eligibility criteria

Among patients with Cardiac implantable electronic device (CIED), subjects with... [+3]

Patients deemed inappropriate to participate in the study by the investigator [+4]

Status: Recruiting

Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter

This observational study aims to evaluate the effectiveness and safety of a circular-shaped pulsed field ablation (PFA) catheter for CTI ablation under the guidance of intracardiac echocardiography (ICE). The main question it aims to answer is: Is the circular-shaped PFA catheter an effective and safe tool for achieving acute success for CTI ablation? Patients undergoing CTI ablation with a circular-shaped PFA catheter will be prospectively enrolled.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Beijing Anzhen HospitalUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

Paroxysmal or persistent atrial fibrillation [+3]

Previous CTI ablation [+7]

Status: Not yet recruiting

Detection of Atrial Fibrillation Through Voice Signal Processing

This study is testing a new technology that listens to a person's voice during short phone calls to help identify heart rhythm problems. The goal is to see if voice signal analysis can tell the difference between a normal rhythm (sinus rhythm) and an irregular rhythm (atrial fibrillation). We are enrolling adults scheduled for a standard heart procedure called cardioversion, which is used to reset the heart to a normal rhythm. Each participant will provide voice recordings through three short phone calls: before cardioversion, just after the procedure, and at a follow-up visit. Results will be compared with standard heart rhythm tests (electrocardiograms or ECGs). This research may lead to a simple, low-cost way to monitor heart rhythms remotely without requiring special devices.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Vital Audio IncUpdated: Oct 8, 2025Duration: 1 Month
Eligibility criteria

Diagnosis of atrial fibrillation and presenting for cardioversion at Allina Heal... [+1]

History of a pacemaker [+4]

Status: Recruiting

Electrophysiological Registry Duesseldorf

This registry at University Hospital Düsseldorf collects retrospective and prospective (from 2019 onward) data on patients undergoing electrophysiological studies (EPS), catheter ablation, and electrical cardioversion. The primary goal is to evaluate safety, efficacy, and clinical outcomes of these standard procedures in routine care. Data will be used for quality assurance and to identify prognostic patient- and procedure-related factors.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Heinrich-Heine University, DuesseldorfUpdated: Sep 29, 2025Locations: 1Duration: 2 Years
Eligibility criteria

Patients who undergo an electrophysiological study (EPS) or electrical cardiover... [+1]

< 18 years [+2]

Status: Recruiting

Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.

Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.

Participants needed: 530
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Jena University HospitalUpdated: Sep 2, 2025Locations: 33
Eligibility criteria

Signed written informed consent [+6]

Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical he... [+10]

Status: Not yet recruiting

Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure

"The primary objective of the study is to evaluate whether the incidence of symptomatic or asymptomatic atrial fibrillation, atrial flutter, and atrial tachycardia within 30 days after percutaneous closure of idiopathic patent foramen ovale is reduced in the beta-blocker treatment group compared to the non-treatment group. The secondary objective is to assess the safety and performance of the Cocoon Patent Foramen Ovale Occluder and collect real-world data on patient outcomes. Patients will be randomly assigned in a 1:1 ratio to either the beta-blocker treatment group or the non-treatment group. Randomization will be performed using a 1:1 allocation ratio with stratification based on (1) PFO device size and (2) sex, employing a block randomization method (mixed block sizes of 4 or 6). This process will be conducted independently through an interactive web response system. The beta-blockers used in this study are extended-release beta-blockers, specifically bisoprolol or nebivolol. The choice between bisoprolol and nebivolol will be determined at the discretion of the investigators, with the initial dose set at the minimum dose for each drug (1.25 mg once daily). During the study period, adjustments to the beta-blocker dose, including maintenance or modification, will be made based on the investigators' clinical judgment, taking into account the patient's heart rate, blood pressure, and medication adherence. All reasons for dose adjustments will be documented in detail."

Participants needed: 350
Trial details
Age: 20+Biological sex: AllType: InterventionalSponsor: Yonsei UniversityUpdated: Aug 14, 2025Locations: 1
Eligibility criteria

Age 19 years or older [+2]

History of paroxysmal, persistent, or permanent atrial arrhythmia [+9]

Status: Recruiting

Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland

The aim of the described project is to establish a multicenter, nationwide registry of atrial arrhythmia ablation procedures using the Pulsed Field Ablation (PFA) method. These procedures have only recently begun to be performed in several centers across Poland. With proper coordination of the registry, this will enable the consolidation of clinical data and the expansion of knowledge regarding the efficacy and safety of these procedures.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Wroclaw Medical UniversityUpdated: Aug 7, 2025Locations: 1Duration: 12 Months
Eligibility criteria

Informed consent obtained from the participant [+1]

Status: Recruiting

Pericardiotomy in Cardiac Surgery

PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.

Participants needed: 1,400
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Population Health Research InstituteUpdated: Jul 14, 2025Locations: 4
Eligibility criteria

Patients greater than or equal to 18 years of age [+2]

History of atrial fibrillation or flutter [+4]

Status: Recruiting

Anteroposterior Versus Anterolateral Electrode Position for Electrical Cardioversion of Atrial Fibrillation

Atrial fibrillation is the most common heart rhythm disorder (arrhythmia) worldwide. Nearly 40 million people are affected by atrial fibrillation worldwide, and this number is expected to increase by over 50% by 2050. Atrial fibrillation can cause strokes, heart attacks, heart failure, poor quality of life and even death. Almost half a million deaths worldwide are expected to be related to atrial fibrillation by 2050, and many billions of dollars are spent on atrial fibrillation related healthcare in North America every year. We believe health outcomes for patients with atrial fibrillation, and healthcare costs associated with treating atrial fibrillation could be improved by optimizing existing treatments for atrial fibrillation and maximizing the likelihood of restoring normal heart rhythm. This allows them to benefit from lower stroke risk, better heart function, fewer symptoms and increased quality of life. Restoring normal sinus rhythm earlier prevents atrial fibrillation from causing permanent structural damage to the heart that in turn, makes atrial fibrillation intractable. Furthermore, patients in whom initial attempts to control atrial fibrillation are unsuccessful frequently require more medications or invasive catheter ablation procedures which are costly and carry substantial risk. Electrical cardioversion is the main way physicians restore normal heart rhythm. In this procedure, the heart is "shocked" back into normal rhythm using two electrodes on the chest. Done correctly, this procedure is safe and effective. Many things are known about electrical cardioversion, for example, the best type and amount of electricity to use. What we don't know is the best position of the electrodes on the chest and whether applying direct, physical pressure to the electrodes makes cardioversion more successful. Our prior research suggests that improving positioning and applying pressure may improve cardioversion, but this finding needs to be verified with a rigorous, dedicated trial. This study will demonstrate whether front-to-back, or front-to-side placement of the electrodes is more effective for electrical cardioversion of atrial fibrillation. We will also demonstrate whether manually applying pressure to the electrodes makes cardioversion more effective. Should our trial demonstrate a benefit for these techniques, we expect them to be universally applied around the world. Because hundreds of thousands of cardioversions are done each year, even small increases in cardioversion success means thousands fewer patients progress to needing more medications or invasive procedures to manage their atrial fibrillation. We will study consenting adults presenting for non-urgent cardioversion of their atrial fibrillation. After explaining the study to participants and gaining their consent, we will randomly assign them to front-to-side or front-to-back electrode placement. Patients who remain in atrial fibrillation after the first shock will randomly receive either manual pressure or not. We will compare the success of cardioversion for front-side versus front-back electrode placement, and for manual pressure versus none. We will evaluate success by using electrocardiograms to assess for restoration of the heart rhythm back to normal. We hypothesize that anterolateral electrode positioning is superior to anteroposterior electrode positioning. We also hypothesize that manual pressure is effective relative to none, when applied in patients who have had one unsuccessful shock already.

Participants needed: 1,500
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: McMaster UniversityUpdated: May 14, 2025Locations: 2
Eligibility criteria

Insufficiently anticoagulation for cardioversion as per Canadian Cardiovascular... [+1]

Status: Not yet recruiting

Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease

This is a prospective, single-arm intervention trial whereby we will test the safety and efficacy of performing pulmonary vein isolation (PVI) using pulsed field ablation (PFA) in adult patients with congenital heart disease (CHD) who are presenting for atrial tachycardia (AT) ablation.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Boston Children's HospitalUpdated: May 13, 2025
Eligibility criteria

Adult patients (>= 18 years of age) with repaired or unrepaired congenital heart...

History of sustained AF and/or previous catheter or surgical pulmonary vein isol...

Status: Recruiting

Clinical Cohort Study - TRUST

The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical cohort study including patients treated with cardiac arrhythmias or at high risk for cardiac arrhythmias. The design enables prospective, low-threshold, near complete inclusion of patients with arrhythmias treated at the UHZ. Collection of routine follow-up data, detailed procedural information and systematic biobanking will enable precise and robust phenotyping.

Participants needed: 5,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Universitätsklinikum Hamburg-EppendorfUpdated: Mar 30, 2025Locations: 1Duration: 10 Years
Eligibility criteria

Cardiac arrhythmia, including congenital cardiac arrhythmia diagnosed at baselin... [+3]

Insufficient knowledge of the German language to understand study documents and... [+1]

Status: Recruiting

Get With the Guidelines Atrial Fibrillation Registry

Get With The Guidelines-Atrial Fibrillation is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.

Participants needed: 17,198
Trial details
Age: 18-125Biological sex: AllType: ObservationalSponsor: American Heart AssociationUpdated: Jan 29, 2025Locations: 1Duration: 3 Days
Eligibility criteria

Patients hospitalized with nonvalvular Atrial Fibrillation or Atrial Flutter

Patients who do not have nonvalvular Atrial Fibrillation or Atrial Flutter [+4]

Status: Recruiting

DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery

This is a multicentre prospective cohort study where patients will receive up to 14 days of continuous ECG monitoring by wearing a portable monitoring device, starting within 72 hours after noncardiac surgery.

Participants needed: 750
Trial details
Age: 18-120Biological sex: AllType: ObservationalSponsor: Population Health Research InstituteUpdated: Nov 7, 2024Locations: 6
Eligibility criteria

an overnight hospital admission after surgery [+6]

History of documented chronic (i.e., non-transient) AF before noncardiac surgery... [+14]

Status: Not yet recruiting

Analysis of the Efficacy and Stability of a Wearable ECG Monitor

This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring

Participants needed: 100
Trial details
Age: 19+Biological sex: AllType: InterventionalSponsor: Mezoo Co., Ltd.Updated: Aug 14, 2024
Eligibility criteria

Adults aged 19 years or older [+2]

Individuals who are unable to provide consent themselves or through a legally de... [+1]

Status: Not yet recruiting

A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation

The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to: Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.

Participants needed: 800
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Shanghai Chest HospitalUpdated: Jun 14, 2024Locations: 5
Eligibility criteria

Age range: 18-80 years. [+3]

Patients with known allergies to alcohol. [+1]

Status: Recruiting

Excessive Supraventricular Activity and Atrial Fibrillation

The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.

Participants needed: 250
Trial details
Age: 70-89Biological sex: AllType: ObservationalSponsor: Karolinska InstitutetUpdated: Mar 6, 2024Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?

The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy. However, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest. The WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.

Participants needed: 2,000
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: St. Antonius HospitalUpdated: Dec 15, 2023Locations: 20
Eligibility criteria

Patients ≥ 18 years [+2]

Contra indication to edoxaban, aspirin or all P2Y12 inhibitors [+19]