NCT07262255

WATCHMAN FLX Pro European Registry

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-valvular Atrial Fibrillation (AF)
• Left Atrial Appendage Closure

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-12-17
• Primary completion: 2027-08-01
• Completion: 2028-09-01
• First posted: 2025-12-03
• Last updated: 2026-04-09

Locations

7 sites across 4 countries: Denmark, Germany, Spain, Switzerland