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WATCHMAN FLX Pro European Registry for Left Atrial Appendage Closure in Non-valvular Atrial Fibrillation
Led by Boston Scientific Corporation · Updated on 2026-05-26
1000
Participants Needed
13
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-world clinical data on patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX Pro device. This registry focuses on adults with non-valvular atrial fibrillation who are eligible or have contraindications for anticoagulation therapy. A subgroup of about 300 patients will have the procedure performed using the VersaCross Connect LAAC Access Solution to aid catheter access. Participants undergo the LAAC procedure with the WATCHMAN FLX Pro device, which aims to prevent blood clots from forming in the heart's left atrial appendage and reduce bleeding risks. In the subregistry, the VersaCross Connect LAAC Access Solution is used during the procedure to facilitate catheter entry via transseptal puncture. The study observes patients receiving these devices in routine clinical practice. Throughout the study, researchers monitor safety events related to both the WATCHMAN FLX Pro device and the VersaCross Connect Access Solution from the procedure until 7 days after or hospital discharge. They also track successful use of the Access Solution by confirming completion of the transseptal puncture. Participants must provide informed consent and attend follow-up visits, with the study planned to conclude in September 2028.
CONDITIONS
Brief Title
WATCHMAN FLX Pro European Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is attempted to be treated with the WATCHMAN FLX Pro LAAC device.
- Subject has non-valvular atrial fibrillation without moderate or greater mitral stenosis or a mechanical heart valve and is clinically indicated for the WATCHMAN FLX Pro LAAC device.
- Subject or legal representative is willing and able to provide informed consent.
- Subject is able and willing to return for required follow-up visits and examinations.
- Subject is aged 18 years or older or of legal age to give informed consent according to state and national law.
You will not qualify if you...
- Subject has a documented life expectancy of less than 12 months.
- Subject is currently enrolled in another investigational study or registry except for mandatory governmental or purely observational registries.
- Intracardiac thrombus is present.
- An atrial septal defect repair or closure device or patent foramen ovale repair or closure device is present.
- The left atrial appendage anatomy cannot accommodate a closure device.
- Subject has known hypersensitivity or contraindications according to the device Instructions for Use.
- Subject is of childbearing potential and is or plans to become pregnant during the study.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and up to 7 days following the procedure or until hospital discharge, whichever is later
Participants undergo the left atrial appendage closure procedure using the WATCHMAN FLX Pro device and VersaCross Connect™ LAAC Access Solution.
1 procedure visit and follow-up visits within 7 days post-procedure
Duration - Up to approximately 5 years until study completion
Participants are observed to collect real world clinical data following the left atrial appendage closure procedure.
Follow-up visits as per clinical routine
Trial Site Locations
Total: 13 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
2
Rigshospitalet Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
3
Kath Krankenhaus St Johann Nepomuk
Erfurt, Germany, 99097
Actively Recruiting
4
Asklepios Klinik Saint Georg
Hamburg, Germany, 20099
Actively Recruiting
5
Asklepios Klinik Nord Heidberg
Hamburg, Germany, 22417
Actively Recruiting
6
Asklepios Klinik Altona
Hamburg, Germany, 22763
Actively Recruiting
7
Centro Cardiologico Monzino
Milan, Italy, 20138
Actively Recruiting
8
Hospital de Leon
León, Spain, 24071
Actively Recruiting
9
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
10
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, Spain, 36001
Actively Recruiting
11
Hospital Clinico Salamanca
Salamanca, Spain, 37007
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12
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
13
INSELSPITAL - Universitätsspital Bern
Bern, Switzerland, CH-3010
Actively Recruiting
Research Team
T
Thomas Näschen, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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