WATCHMAN FLX Pro European Registry

NCT07262255 | Recruiting

• 1 other identifier: S2603
• Study Type: interventional
• Target: 1,000
• Locations: 4 countries
• Sites: 7

Brief 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

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

Keywords

LAAC

Outcome Measures

Primary Outcomes (3)

• 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.

  Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later

• 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

  Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later

• 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).

  Completion of transseptal puncture

Study Arms (1)

WATCHMAN FLX Pro

OTHER

This arm is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. Approximately 300 patients undergo the LAAC procedure in conjunction with the use of the VersaCross Connect™ LAAC Access Solution.

Device: Left atrial appendage closure

Interventions

Left atrial appendage closure DEVICE

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.

WATCHMAN FLX Pro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

Kath Krankenhaus St Johann Nepomuk

Erfurt, 99097, Germany

RECRUITING

Asklepios Klinik Saint Georg

Hamburg, 20099, Germany

RECRUITING

Asklepios Klinik Nord Heidberg

Hamburg, 22417, Germany

RECRUITING

Hospital de Leon

León, 24071, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Marek Grygier, Prof. MD, PHD

  Uniwersytecki Szpital Kliniczny w Poznaniu

  PRINCIPAL INVESTIGATOR

• Arian Sultan, Prof. MD

  Asklepios Klinik Saint Georg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Näschen, PhD

CONTACT

+491707828594; Thomas.Naeschen@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Registry

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); CH (1); DE (3); DK (1)