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J-Valve TF Early Feasibility Study

Study acronym: JVTF EFS
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Primary completion date: Mar 4, 2024 to Jul 17, 2024
    • Study completion date: Jun 25, 2029 to Aug 25, 2029
    • Study description revised
    v8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v7
  4. Site details revised at 1 of 9 sitesv6
  5. Enrollment target: 15 to 25v5 Show 4 more changesShow less
    • Study sites: 6 to 9
    • Primary completion date changed from estimate of Jan 30, 2024 to Mar 4, 2024
    • Study completion date: Jan 30, 2029 to Jun 25, 2029
    • Eligibility criteria expanded, about 69 words
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 5 to 6v4
  2. Study sites: 3 to 5v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Oct 1, 2023 to Oct 16, 2023
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.
Trial Details
NCT Number NCT06034028
Lead Sponsor JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Conditions
(from sponsor)		 Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation
Related terms Aortic Valve Disease, Aortic Valve Insufficiency, Heart Valve Diseases
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov