Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke

Study acronym: SAFE-PROTECT
StatusUnknown
PhaseNot applicable
Started

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2023); last known: Active, Not Recruiting
  2. Trial status: Not Yet Recruiting to Active, Not Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date changed from estimate of Jun 30, 2022 to Sep 27, 2022
    • Study completion date: Jun 30, 2026 to Sep 30, 2026
    • Start date changed from estimate of Dec 31, 2020 to Mar 3, 2021
  3. Re-verified, no change to tracked fieldsv3
  4. Primary completion date: Dec 31, 2021 to Jun 30, 2022v2 Show 6 more changesShow less
    • Start date: Oct 31, 2020 to Dec 31, 2020
    • Enrollment target: 154 to 210
    • Study completion date: Dec 31, 2025 to Jun 30, 2026
    • Eligibility criteria expanded, about 14 words
    • Study description shortened, about 19 words
    • Study title expanded, about 2 words
  5. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have contraindications for long-term anti-coagulation. And to support registration approval from National Medical Products Administration (NMPA).
Trial Details
NCT Number NCT04479722
Lead Sponsor Shanghai MicroPort Medical (Group) Co., Ltd.
Conditions
(from sponsor)		 Atrial Fibrillation, Stroke
Related terms Atrial Fibrillation, Ischemic Stroke, Stroke
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov