Elite AF IDE Trial (Elite AF)

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoints added 0 → 2 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 10 more changesShow less
    • Phase changed: not specified → not applicable
    • Sponsor changed: [Redacted] to Boston Scientific Corporation
    • Trial status changed: Withheld → Recruiting
    • Enrollment changed: None → 400
    • Interventions modified
    • Trial arms changed: 0 → 1
    • Primary completion date: Jan 2028
    • Study completion date: Nov 2032
    • Start date: Sep 18, 2026
    • Study title shortened, about 7 words
  2. 9 versions Re-verified since Jan 16, 2026, no change to tracked fieldsv2-v10
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke.
Trial Details
NCT Number NCT07287436
Lead Sponsor Boston Scientific Corporation
Conditions
(from sponsor)		 Atrial Fibrillation (AF), Stroke
Related terms Atrial Fibrillation, Stroke
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov