WATCHMAN FLX Pro European Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Left atrial appendage closure
Treatment groups
1,000 Participants
are divided into 1 treatment groupLocations
14Denmark
Aarhus University Hospital8200, Aarhus Denmark
Rigshospitalet Copenhagen2100, Copenhagen Denmark
Germany
Kath Krankenhaus St Johann Nepomuk99097, Erfurt Germany
Asklepios Klinik Altona22763, Hamburg Germany
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov