HEAL-LAA Clinical Trial
About the study
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Subject is of legal age to participate in the study.
- Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
- Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.
- Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
- Subject is able and willing to return for required follow-up visits and examinations.
EXCLUSION CRITERIA
Exclusion Criteria:
- Subject has a documented life expectancy of less than 6 months.
- Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
- 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.
- The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated.
- Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
- There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.
- Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Atrial Fibrillation,Bleeding,Stroke
Age
18+
Phase
NA
Participants Needed
1000
Est. Completion Date
Jun 30, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Boston Scientific Corporation
ClinicalTrials.gov NCT Identifier
NCT05809596
Study Number
S2504
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