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No phaseActive, not recruiting

The JenaValve ALIGN-AR LVAD Registry (JENA-VAD)

Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)

Sponsor
JenaValve Technology, Inc. (Industry)
Enrollment
50 enrolled
Conditions
Aortic Regurgitation; Aortic Valve Insufficiency; Aortic Insufficiency; Aortic Valve Disease; Left Ventricular Dysfunction
Interventions
JenaValve Trilogy Heart Valve System
Ages
adults, older adults
Registry
NCT06594705

Full record on ClinicalTrials.gov

From the registry

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

Primary outcomes

  • Primary Efficacy Endpoint: Modified VARC-3 Device Success
  • Primary Safety Endpoint: VARC-3 Early Safety Composite

History

  1. Study completion expected

  2. Completion moved to Aug 9, 2026

    , from Aug 2027 to Aug 9, 2026

  3. Last registry update

  4. Primary completion

  5. Started

  6. Registered