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 FLXâ„¢ Pro device. In a subregistry with approximately 300 patients, it is intended to use the VersaCross Connectâ„¢ LAAC Access Solution.
Who can participate
Age range18 Years
SexALL
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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
✕. 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.
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 Connectâ„¢ 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 Connectâ„¢ LAAC Access Solution treatment