Actively Recruiting
WATCHMAN FLX Pro European Registry
Led by Boston Scientific Corporation · Updated on 2026-05-08
1000
Participants Needed
11
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
WATCHMAN FLX Pro European Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is planned to be treated with the WATCHMAN FLX Pro LAAC device
- Patient has non-valvular atrial fibrillation and is clinically indicated for the WATCHMAN FLX Pro device per Instructions for Use
- Patient or legal representative is willing and able to provide informed consent
- Patient is able and willing to attend required follow-up visits and examinations
- Patient is 18 years or older or of legal consenting age according to local laws
You will not qualify if you...
- Patient has a documented life expectancy of less than 12 months
- Patient is currently enrolled in another investigational study or registry, except mandatory governmental or purely observational registries
- Presence of intracardiac thrombus (blood clot in the heart)
- Presence of an atrial septal defect repair or closure device or a patent foramen ovale repair or closure device
- Left atrial appendage anatomy unsuitable for closure device
- Known hypersensitivity or contraindications as described in the device Instructions for Use
- Female patient of childbearing potential who is pregnant or plans to become pregnant during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 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
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
11
INSELSPITAL - Universitätsspital Bern
Bern, Switzerland, CH-3010
Actively Recruiting
Research Team
T
Thomas Näschen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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