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THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Jun 2022 to Aug 29, 2022
    • Study completion date: Jun 2022 to Sep 29, 2027
    v11
  2. Primary completion date: Jun 2021 to Jun 2022v10 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 70 to 100
    • Study completion date: Jun 2026 to Jun 2022
    • Site details revised at 19 of 19 sites
  3. Study sites: 21 to 19
    • Collaborators shortened, about 5 words
    • Study title expanded, about 1 word
    v9
  4. Primary completion date: Jun 2020 to Jun 2021
    • Study completion date: Jun 2025 to Jun 2026
    v8
  5. Secondary endpoints revised (4)v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Apr 2016 to Apr 20, 2018v6 Show 6 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 17 to 21
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Primary endpoint revised
    • Study title expanded, about 3 words
  2. Primary completion date: Jul 2019 to Jun 2020v5 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 14 to 17
    • Study completion date: Jul 2024 to Jun 2025
    • Secondary endpoints revised (4)
    • Study description shortened, about 161 words
  3. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Enrollment target: 30 to 70
    • Study sites: 18 to 14
    v4
  4. Phase: Phase 1 to Not applicablev3 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 18
    • Study completion date: Jul 2019 to Jul 2024
    • Start date: Jun 2016 to Apr 2016
    • Secondary endpoints revised (4)
    • Study description expanded, about 210 words
  5. Lead sponsor: [Redacted] to JenaValve Technology, Inc.v2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary and study completion dates: Jul 2019
    • Start date: Jun 2016
    • Study title shortened, about 7 words
    • Collaborators expanded, about 5 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Trial Details
NCT Number NCT02732704
Lead Sponsor JenaValve Technology, Inc.
Conditions
(from sponsor)		 Aortic Regurgitation
Related terms Aortic Valve Disease, Aortic Valve Insufficiency
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov