HEAL-LAA Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device

Conditions
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Stroke, Atrial Fibrillation, Bleeding

Intervention / Treatment
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* Device: WATCHMAN FLX Pro LAAC Device


Participation Criteria
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Eligibility Criteria
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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: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device Group<br>WATCHMAN FLX Pro LAAC Device Implantation | Device: WATCHMAN FLX Pro LAAC Device<br>* Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device<br>* Other names: Left Atrial Appendage Closure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of leak (>5 mm) for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than the rate of leak (> 5mm) of the performance goal. | Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset. | 45 days | 
| The composite rate of all-cause mortality, all stroke, systemic embolism, and major bleeding for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than a performance goal. | Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset. | 6 months |