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NCT06174103 · ClinicalTrials.gov registry record · NA

BiVACOR® Total Artificial Heart Early Feasibility Study

A NA study of Heart Failure and Biventricular Failure, sponsored by BiVACOR.

Recruiting
Registry status
NA
Development phase
5
Enrollment target
4
Study locations

NCT06174103: Recruiting NA study of Heart Failure and Biventricular Failure, sponsored by BiVACOR.

NCT06174103 is a NA study of Heart Failure and Biventricular Failure that is actively recruiting participants, run by BiVACOR. The registered enrollment target is 5 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06174103, a NA study of Heart Failure and Biventricular Failure, is actively recruiting participants, sponsored by BiVACOR.

RECRUITING
Registry status
NA
Development phase
5 participants
Enrollment target
4
Study locations

Study Summary

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.

Primary Outcome

Survival on the original BiVACOR pump

Conditions Studied

Heart Failure Biventricular Failure

Interventions

  • DEVICE BiVACOR TAH System

Study Locations (4)

Arizona

  • Banner - University Medical Center Phoenix - Phoenix

North Carolina

  • Duke University Hospital - Durham

Ohio

  • The Christ Hospital - Cincinnati

Texas

  • Texas Heart Institute / Baylor St. Luke's Medical Center - Houston

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2024-06-26
Est. Completion 2026-12
Phase NA
BiVACOR

1 total trials

What NCT06174103 shows while recruiting

NCT06174103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which BiVACOR TAH System is the first listed.

NCT06174103 reports a single indexed study location in Arizona, North Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT06174103 about?

NCT06174103 is a clinical study titled "BiVACOR® Total Artificial Heart Early Feasibility Study". 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 me...

What is the current status of trial NCT06174103?

This trial is currently recruiting. It is a NA study. The enrollment target is 5 participants. The study started on 2024-06-26. Estimated completion is 2026-12.

What conditions does trial NCT06174103 study?

This clinical trial studies the following conditions: Heart Failure, Biventricular Failure.

What interventions are being tested in trial NCT06174103?

The interventions under investigation include: BiVACOR TAH System (DEVICE).

Who is sponsoring clinical trial NCT06174103?

This trial is sponsored by BiVACOR, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06174103 being conducted?

This trial has 4 study locations across Arizona, North Carolina, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Heart Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06174103's enrollment target sits among peer trials

5 395th of 397 higher than 2 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06174103

Source: ClinicalTrials.gov NCT06174103, the US trial registry maintained by the National Library of Medicine. NCT06174103 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.