WATCHMAN FLX Pro European Registry

May 7, 2026 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Principal Investigator:
          • Jens Erik Nielsen-Kudsk, Prof.
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet Copenhagen
        • Principal Investigator:
          • Ole De Backer, Prof.
  • Germany
      • Erfurt, Germany, 99097
        • Recruiting
        • Kath Krankenhaus St Johann Nepomuk
        • Principal Investigator:
          • Henning Ebelt, Prof.
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
        • Principal Investigator:
          • Martin Bergmann, Prof.
      • Hamburg, Germany, 20099
        • Recruiting
        • Asklepios Klinik Saint Georg
        • Principal Investigator:
          • Arian Sultan, Prof.
      • Hamburg, Germany, 22417
        • Recruiting
        • Asklepios Klinik Nord Heidberg
        • Principal Investigator:
          • Alexander Ghanem, Prof.
  • Italy
      • Milan, Italy, 20138
        • Recruiting
        • Centro Cardiologico Monzino
        • Principal Investigator:
          • Claudio Tondo, Prof.
  • Spain
      • León, Spain, 24071
        • Recruiting
        • Hospital de Leon
        • Principal Investigator:
          • Armando Perez de Prado, Prof.
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Jose Ignacio Garcia Bolao, Prof.
        • Principal Investigator:
          • Jose Ignacio Garcia Bolao, Prof.
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Principal Investigator:
          • Christian Sticherling, Prof.
      • Bern, Switzerland, CH-3010
        • Recruiting
        • Inselspital - Universitätsspital Bern
        • Principal Investigator:
          • Lorenz Räber, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device.
  2. 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).
  3. Subject or legal representative who are willing and capable of providing informed consent.
  4. Subject is able and willing to return for required follow-up visits and examinations.
  5. 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 Criteria:

  1. Subject has a documented life expectancy of less than 12 months.
  2. 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.
  3. Intracardiac thrombus is present.
  4. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
  5. The LAA anatomy will not accommodate a Closure Device.
  6. Subject has a known hypersensitivity or contraindications according to IFU.
  7. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: WATCHMAN FLX Pro

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a safety event treated with the WATCHMAN FLX Pro
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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).
Completion of transseptal puncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Marek Grygier, Prof. MD, PHD, Uniwersytecki Szpital Kliniczny w Poznaniu
  • Principal Investigator: Arian Sultan, Prof. MD, Asklepios Klinik Saint Georg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Left Atrial Appendage Closure

Clinical Trials on Left atrial appendage closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe