WATCHMAN FLX Pro European Registry

Recruiting now

Conditions studied: Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure

In brief

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.

Key facts

Study ID

NCT07262255

Run by

Boston Scientific Corporation

People needed

1000

Starts

2025-12-17

Expected to finish

2028-09-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Rigshospitalet Copenhagen — Copenhagen, Denmark (enrolling)
• Herz-und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen, Germany (enrolling)
• Charite, Campus Benjamin Franklin — Berlin, Germany (enrolling)
• Kath Krankenhaus St Johann Nepomuk — Erfurt, Germany (enrolling)
• Asklepios Klinik Saint Georg — Hamburg, Germany (enrolling)
• Asklepios Klinik Nord Heidberg — Hamburg, Germany (enrolling)
• Asklepios Klinik Altona — Hamburg, Germany (enrolling)
• Universitaetsklinikum Schleswig-Holstein — Lübeck, Germany (enrolling)
• Centro Cardiologico Monzino — Milan, Italy (enrolling)
• Ospedale Sacro Cuore Don Calabria — Verona, Italy (enrolling)
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland (enrolling)
• Hospital de Leon — León, Spain (enrolling)
• Clinica Universidad de Navarra — Pamplona, Spain (enrolling)
• Complejo Hospitalario Universitario de Pontevedra — Pontevedra, Spain (enrolling)
• Hospital Clinico Salamanca — Salamanca, Spain (enrolling)
• University Hospital Basel — Basel, Switzerland (enrolling)
• INSELSPITAL - Universitätsspital Bern — Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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