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

Inclusion Criteria5

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.
Subject whose age is 18 years or above, or who is of legal age to give informed consent specific to state and national law.

Exclusion Criteria7

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.
The LAA anatomy will not accommodate a Closure Device.
Subject has a known hypersensitivity or contraindications according to IFU.
Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.

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.