European registry of the WATCHMAN FLX Pro left atrial appendage closure device

WATCHMAN FLX Pro European Registry

This registry tests how the WATCHMAN FLX Pro device works for closing the left atrial appendage in adults with non-valvular atrial fibrillation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boston Scientific Corporation (Industry-sponsored)
• Locations: 11 sites (Aarhus and 10 other locations)
• Trial ID: NCT07262255 on ClinicalTrials.gov

What this trial studies

The WATCHMAN FLX Pro European registry prospectively collects real-world clinical data on patients undergoing left atrial appendage closure with the WATCHMAN FLX Pro device across multiple European centers. Enrolled adults treated with the device per the Instructions for Use are followed at scheduled visits to capture procedural details, device performance, and safety and effectiveness outcomes. A prespecified subregistry of about 300 patients will use the VersaCross Connect LAAC Access Solution to capture outcomes related to that access approach. Aggregated data will be used to describe real-world use patterns, complication rates, and short- to mid-term clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with non-valvular atrial fibrillation who are clinically indicated for left atrial appendage closure with the WATCHMAN FLX Pro device and can provide informed consent and attend follow-up visits.

Not a fit: Patients with a life expectancy under 12 months, those with contraindications such as mechanical heart valves or moderate-to-severe mitral stenosis, or those unable to comply with follow-up are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the registry could clarify real-world safety and effectiveness of WATCHMAN FLX Pro and help clinicians choose patients and techniques that produce the best outcomes.

How similar studies have performed: Pivotal trials and prior registries of WATCHMAN and WATCHMAN FLX devices have demonstrated favorable safety and stroke-reduction outcomes, so this registry builds on existing evidence.

Eligibility criteria

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.

Where this trial is running

Aarhus and 10 other locations

• Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• Rigshospitalet Copenhagen — Copenhagen, Denmark (Recruiting)
• Kath Krankenhaus St Johann Nepomuk — Erfurt, Germany (Recruiting)
• Asklepios Klinik Saint Georg — Hamburg, Germany (Recruiting)
• Asklepios Klinik Nord Heidberg — Hamburg, Germany (Recruiting)
• Asklepios Klinik Altona — Hamburg, Germany (Recruiting)
• Centro Cardiologico Monzino — Milan, Italy (Recruiting)
• Hospital de Leon — León, Spain (Recruiting)
• Clinica Universidad de Navarra — Pamplona, Spain (Recruiting)
• University Hospital Basel — Basel, Switzerland (Recruiting)
• INSELSPITAL - Universitätsspital Bern — Bern, Switzerland (Recruiting)

Study contacts

• Principal investigator: Marek Grygier, Prof. MD, PHD — Uniwersytecki Szpital Kliniczny w Poznaniu
• Study coordinator: Thomas Näschen, PhD

Conditions Non-valvular Atrial Fibrillation; Left Atrial Appendage Closure; LAAC