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NCT02931240 · ClinicalTrials.gov registry record · NA
BioVentrix Revivent TC™ System Clinical Study
A NA study of Ventricular Dysfunction, Left, sponsored by BioVentrix.
- Active
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 20
- Study locations
NCT02931240: Active NA study of Ventricular Dysfunction, Left, sponsored by BioVentrix.
NCT02931240 is a NA study of Ventricular Dysfunction, Left that is active but no longer recruiting, run by BioVentrix. The registered enrollment target is 126 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02931240, a NA study of Ventricular Dysfunction, Left, is active but no longer recruiting, sponsored by BioVentrix.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 20
- Study locations
Study Summary
A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.
Primary Outcome
Composite primary safety endpoint of all cause death, placement of a mechanical support device intra or post-op (IABP, VAD, ECMO or catheter based), emergent cardiac surgery including reoperation for bleeding or tamponade, prolonged mechanical ventilation, renal failure and clinically important stroke (Rankin Score of 4 or higher) through 30-days post procedure. Data from the patients treated with the Revivent TC System will be compared to surgical outcomes data from the Society for Thoracic Sur
Conditions Studied
Interventions
- DEVICE Revivent TC
Study Locations (20)
California
- Ronald Regan UCLA Medical Center - Los Angeles
- University of California, San Francisco - San Francisco
- Los Robles Hospital & Medical Center - Thousand Oaks
Georgia
- Emory University Hospital Midtown - Atlanta
- WellStar Health System - Marietta
New York
- Mount Sinai Hospital - New York
- New York Presbyterian Hospital - New York
Pennsylvania
- UPMC Pinnacle - Harrisburg
- Penn State Health Milton S. Hershey Medical Center - Hershey
Arizona
- University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute - Phoenix
Florida
- Baptist Hospital of Maimi - Miami
Illinois
- Memorial Medical Center - Springfield
Louisiana
- Terrebonne General Medical Center - Houma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2017-08-29 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
What the registry record for NCT02931240 still lists
NCT02931240 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Ventricular Dysfunction, Left appearing as the primary indexed condition, and to 1 intervention - of which Revivent TC is the first listed.
NCT02931240 names 20 study sites across 15 states, led by California, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT02931240 about?
NCT02931240 is a clinical study titled "BioVentrix Revivent TC™ System Clinical Study". A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in...
What is the current status of trial NCT02931240?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2017-08-29. Estimated completion is 2027-06-30.
What conditions does trial NCT02931240 study?
This clinical trial studies the following conditions: Ventricular Dysfunction, Left.
What interventions are being tested in trial NCT02931240?
The interventions under investigation include: Revivent TC (DEVICE).
Who is sponsoring clinical trial NCT02931240?
This trial is sponsored by BioVentrix, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02931240 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ventricular Dysfunction, Left
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 NCT02931240's enrollment target sits among peer trials
126 749th of 2000 higher than 1,248 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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