WATCHMAN FLX Pro European Registry

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

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.

Primary outcomes

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.
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
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).

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Näschen, PhD

CONTACT

[email protected]

+491707828594

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Dec 3, 2025
Registry last updated: Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed