RecruitingNot ApplicableNCT07262255

WATCHMAN FLX Pro European Registry

Sponsor

Boston Scientific Corporation

Enrollment

1,000 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study is tracking real-world outcomes in patients who receive the WATCHMAN FLX Pro device — a small implant placed inside the heart to block the left atrial appendage (a small pouch where clots commonly form) — as an alternative to long-term blood thinners in people with atrial fibrillation. **You may be eligible if...** - You have non-valvular atrial fibrillation (AFib not caused by a mechanical heart valve or severe mitral stenosis) - Your doctor has recommended the WATCHMAN FLX Pro device as part of your standard care - You are able and willing to attend follow-up visits **You may NOT be eligible if...** - You have moderate or severe mitral valve stenosis or a mechanical heart valve - You cannot receive the device per the manufacturer's guidelines - You are unwilling or unable to follow study visit requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELeft 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.