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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with a safety event treated with the WATCHMAN FLX Pro
Timeframe: Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later
2
Number of participants with a safety event treated with the VersaCross Connect™ LAAC Access Solution
Timeframe: Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later
3
Number of participants with a successful VersaCross Connect™ LAAC Access Solution treatment
. 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.