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J-Valve Transfemoral Pivotal Study

Study acronym: JOURNEY
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites expanded: 37 → 40 locations
    • Eligibility criteria expanded, about 32 words
    v14
  2. Study sites: 39 to 37v13
  3. Study sites: 31 to 39v12
  4. Study sites revised (31)v11
  5. Trial status: Active, Not Recruiting to Recruitingv10 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 27 to 31
    • Primary completion date: Dec 2027 to Feb 2028
    • Study completion date: Dec 2031 to Feb 2032
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 3 to 5
    • Study description revised
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 21 to 27v9
  2. Study sites: 18 to 21v8
  3. Study sites: 9 to 18
    • Collaborators: 3 to 2
    v7
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v6
  5. Study sites: 8 to 9v5
  6. Study sites: 3 to 8v4
  7. Primary completion date: Sep 2027 to Dec 2027v3 Show 4 more changesShow less
    • Study completion date: Sep 2031 to Dec 2031
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: 1 to 3
    • Study description expanded, about 49 words
  8. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Primary completion date: Jul 2026 to Sep 2027
    • Enrollment target: 171 to 194
    • Study sites: 0 to 3
    • Study completion date: Jul 2030 to Sep 2031
    • Start date changed from estimate of Jul 2024 to Oct 17, 2024
    • Secondary endpoints: 2 to 1
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 4 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.
Trial Details
NCT Number NCT06455787
Lead Sponsor JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Collaborators: Minneapolis Heart Institute Foundation, Cardiovascular Research Foundation, New York
Conditions
(from sponsor)		 Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Related terms Aortic Valve Insufficiency
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov