No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
Boston Scientific Corporation · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.