WATCHMAN FLX Pro European Registry

September 1, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Herz-und Diabeteszentrum Nordrhein-Westfalen
        • Principal Investigator:
          • Werner Scholtz, Prof.
      • Berlin, Germany, 12203
        • Recruiting
        • Charite, Campus Benjamin Franklin
        • Principal Investigator:
          • Carsten Skurk, Prof.
      • 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.
      • Lübeck, Germany, 23582
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein
        • Principal Investigator:
          • Ingo Eitel, Prof.
  • Italy
      • Catania, Italy, 95123
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco
        • Principal Investigator:
          • Carmelo Grasso, Prof.
      • Milan, Italy, 20138
        • Recruiting
        • Centro Cardiologico Monzino
        • Principal Investigator:
          • Claudio Tondo, Prof.
      • Verona, Italy, 37126
        • Recruiting
        • Ospedale Sacro Cuore Don Calabria
        • Principal Investigator:
          • Giulio Molon, Prof.
  • Poland
      • Poznan, Poland, 61-848
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
        • Principal Investigator:
          • Marek Grygier, 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.
      • Pontevedra, Spain, 36001
        • Recruiting
        • Complejo Hospitalario Universitario de Pontevedra
        • Principal Investigator:
          • Diego Lopez Otero, MD
      • Pontevedra, Spain, 36001
        • Recruiting
        • Complejo Hospitalario de Pontevedra
        • Principal Investigator:
          • Ivan Tomas Gomez-Blazquez, Prof.
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Clinico Salamanca
        • Principal Investigator:
          • Ignacio Cruz Gonzalez, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospital

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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