WATCHMAN FLX Pro European Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. In a subregistry with approximately 300 patients, it is intended to use the VersaCross Connect™ LAAC Access Solution.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device.
Subject has non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) and is clinically indicated for a WATCHMAN FLX™ Pro LAAC device, per the Instructions for Use (IFU).
Subject or legal representative who are willing and capable of providing informed consent.
Subject is able and willing to return for required follow-up visits and examinations.
Disqualifiers
Subject has a documented life expectancy of less than 12 months.
Subject who is currently enrolled in another investigational study or registry except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
Intracardiac thrombus is present.
An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
Trial population
Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Left atrial appendage closure
DeviceThe WATCHMAN FLX Pro LAAC Technology is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in adult patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy. The VersaCross Connect™ LAAC Access Solution is indicated for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: WATCHMAN FLX Pro1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with a safety event treated with the WATCHMAN FLX Pro
Proportion of subjects with one or more of the following events between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and minor nonsurgical treatments of access site complications are excluded from this endpoint.
Time frame
Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later2
Number of participants with a safety event treated with the VersaCross Connect™ LAAC Access Solution
Proportion of subjects with one or more of the following events between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later: For all enrolled subjects, who had an attempt to insert the VersaCross Connect™ LAAC Access Solution device, the composite rate of all-cause death, all stroke, systemic embolism, pericardial effusion resulting in interventions\*, and ISTH major bleeding. \*Pericardial effusion/tamponade requiring pericardiocentesis or surgery to treat
Time frame
Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later3
Number of participants with a successful VersaCross Connect™ LAAC Access Solution treatment
VersaCross Connect™ LAAC Access Solution acute procedural success: Acute Procedural Success is defined as transseptal puncture success (VersaCross RF-wire crossing into left atrium).
Time frame
Completion of transseptal punctureSponsors and contacts
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Source ClinicalTrials.gov