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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2024-06-26 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06174103
The ClinicalTrials.gov registry entry for NCT06174103 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (100% lower). The listed sponsor is BiVACOR, which has 1 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.