BiVACOR® Total Artificial Heart Early Feasibility Study

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Aug 2025 → Dec 2026
See other at-risk trials from BiVACOR Inc.

Record History

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  1. Primary completion pushed from Aug 2025 to Dec 2026 Show 4 more changesShow less
    • Enrollment increased: 5 → 20 participants
    • Study completion pushed from Dec 2026 to Mar 2027
    • Eligibility criteria expanded, about 45 words
    • Site details revised at 1 of 4 sites
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Mar 2024 to Jun 26, 2024
    • Eligibility criteria expanded, about 10 words
    v2
  3. Study First Submitted
  • 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.
BiVACOR Inc.
1 trial monitored
See 1 trial at risk
Heart Disease
8,814 trials monitored
See 428 trials at risk
Heart Failure
2,000 trials monitored
See 115 trials at risk
The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects.
Trial Details
NCT Number NCT06174103
Lead Sponsor BiVACOR Inc.
Conditions
(from sponsor)		 Heart Failure, Biventricular Failure
Related terms Heart Failure
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov