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The JenaValve ALIGN-AR LVAD Registry

Study acronym: JENA-VAD
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 22, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial status changed: Recruiting → Active, Not Recruiting
    • Study sites: 15 to 14
    v6
  2. Minor Study sites: 14 to 15v5
  3. Notable Primary completion date: Dec 2025 to Aug 2026
    • Study sites: 7 to 14
    • Study completion date: Dec 2026 to Aug 2027
    • Eligibility criteria expanded, about 37 words
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 7
    • Start date changed from estimate of Oct 2024 to Dec 9, 2024
    v3
  5. Minor Study sites: 0 to 1v2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Trial Details
NCT Number NCT06594705
Lead Sponsor JenaValve Technology, Inc.
Conditions
(from sponsor)
Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease, Left Ventricular Dysfunction
Related terms Aortic Valve Disease, Aortic Valve Insufficiency, Ventricular Dysfunction, Left
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov