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Not Applicable
Device Group for Stroke (HEAL-LAA Trial)
N/A
Recruiting
Led By Mohamed Kanj, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
HEAL-LAA Trial Summary
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.
Eligible Conditions
- Stroke
- Bleeding
- Atrial Fibrillation
HEAL-LAA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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.
HEAL-LAA Trial Design
1Treatment groups
Experimental Treatment
Group I: Device GroupExperimental Treatment1 Intervention
WATCHMAN FLX Pro LAAC Device Implantation
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
720 Previous Clinical Trials
932,027 Total Patients Enrolled
10 Trials studying Stroke
9,033 Patients Enrolled for Stroke
Mohamed Kanj, MDPrincipal InvestigatorThe Cleveland Clinic
Oluseun Alli, MDPrincipal InvestigatorNovant Health Heart & Vascular Institute
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