WATCHMAN FLX Pro European Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

Left atrial appendage closure: The 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.

Study summary

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

Primary outcome measure(s)

• Number of participants with a safety event treated with the WATCHMAN FLX Pro — Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later
  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.
• Number of participants with a safety event treated with the VersaCross Connect™ LAAC Access Solution — Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later
  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
• Number of participants with a successful VersaCross Connect™ LAAC Access Solution treatment — Completion of transseptal puncture
  VersaCross Connect™ LAAC Access Solution acute procedural success: Acute Procedural Success is defined as transseptal puncture success (VersaCross RF-wire crossing into left atrium).

Trial sites (20)

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