The Impact of Atrial Pressure Change Before and After Combined Procedure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital
About this trial
One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Although it could achieve considerable rhythm control and stroke prophylaxis, a number of patients has experienced progressive heart failure after the procedure. Notably, previous studies indicate that both pulmonary vein isolation by CA and LAAC could significantly increase left atrial pressure, while currently no study has investigated left atrial pressure change in patients underwent combined procedure. The investigators hypothesise that combined procedure would significantly increase left atrial pressure and subsequently deteriorate cardiac function. Therefore, the investigators aim to measure the left and right atrial pressure change before and after CA and LAAC in combined procedure, and investigate the influence of the pressure change on clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months;
At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
Contraindicated to oral anticoagulation (OAC);
Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment.
Disqualifiers
Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication;
Concomitant arrhythmia including atrial flutter, ventricular tachycardia;
A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation;
A previous history of cardiac surgery including any valvular replacement, septal repair;
Trial population
The study is designed to investigate the change of atrial pressure before and after combined procedure of catheter ablation and left atrial appendage closure, and evaluate its influence on prognosis. This study aims to recruit patients diagnosed with atrial fibrillation who are eligible for combined procedure. Patients with paroxysmal, persistent, or longstanding persistent AF are included, whether it is new-onset or drug refractory.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Atrial pressure measurement using transseptal puncture sheath
Diagnostic testboth left and right atrial pressure was measured using transseptal puncture sheath before and after combined procedure
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Combined procedure1 intervention
Trial outcomes
Primary outcomes
1
Composite endpoint
Rehospitalization due to heart failure and death due to cardiovascular disease
Time frame
From date of inclusion until the date of first documented rehospitalization due to heart failure or date of death due to cardiovascular disease, whichever came first, assessed up to 60 monthsSecondary outcomes
1
All-cause mortality
death of any reason
Time frame
From date of inclusion until the date of documented death of any reason, assessed up to 60 months2
Major cardiovascular adverse event
cardiovascular events including myocardial infarction, malignant arrhythmia, acute heart failure, cardiac tamponade.
Time frame
From date of inclusion until the date of first documented cardiovascular events mentioned above, assessed up to 60 months3
Rehospitalization due to cardiovascular diseases
Rehospitalization due to any cardiovascular diseases
Time frame
From date of inclusion until the date of first documented rehospitalization due to cardiovascular diseases, assessed up to 60 months4
Early recurrence of atrial arrhythmia
Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter
Time frame
From time of completion of combined procedure until the third month since the procedureSponsors and contacts
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Source ClinicalTrials.gov