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NCT06813820 · ClinicalTrials.gov registry record · NA
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
A NA study of CHF and Left Ventricle Remodeling, sponsored by BioVentrix.
- Recruiting
- Registry status
- NA
- Development phase
- 135
- Enrollment target
- 6
- Study locations
NCT06813820: Recruiting NA study of CHF and Left Ventricle Remodeling, sponsored by BioVentrix.
NCT06813820 is a NA study of CHF and Left Ventricle Remodeling that is actively recruiting participants, run by BioVentrix. The registered enrollment target is 135 participants, below the 172-participant average among 5 other CHF trials with a reported enrollment target (22% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06813820, a NA study of CHF and Left Ventricle Remodeling, is actively recruiting participants, sponsored by BioVentrix.
- RECRUITING
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
- 6
- Study locations
Study Summary
A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.
Primary Outcome
Composite of Major Adverse Events at 30 days comprised of Clinical Events Committee (CEC) Adjudication of Mortality, Myocardial Infarction (MI), Major Stroke, Prolonged Intubation \>48hrs, Need for Inotropic support \>24hrs, Mech circulatory support intra or post op, BARC 4 or 5 bleeding, reoperation, serious infection related to device or procedure, Cardiac tamponade, or Initiation of renal replacement therapy, with a Performance Goal (PG) of 70% (upper bound of the 97.5% one sided CI)
Conditions Studied
Interventions
- DEVICE Revivent System
Study Locations (6)
Arizona
- Banner University Medical Center - Phoenix
Florida
- Baptist Health South Florida - Miami
Illinois
- University of Chicago - Chicago
Missouri
- Saint Luke's Hospital of Kansas City - Kansas City
Oklahoma
- Oklahoma Heart Hospital - Oklahoma City
Pennsylvania
- Penn State Health - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2025-09-29 |
| Est. Completion | 2032-08 |
| Phase | NA |
What NCT06813820 shows while recruiting
NCT06813820 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 172-participant average among 5 other CHF trials with a reported enrollment target (22% lower).
The record links to 3 conditions, with CHF appearing as the primary indexed condition, and to 1 intervention - of which Revivent System is the first listed.
NCT06813820 lists 6 locations in 6 states (Arizona, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT06813820 about?
NCT06813820 is a clinical study titled "RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial". A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary...
What is the current status of trial NCT06813820?
This trial is currently recruiting. It is a NA study. The enrollment target is 135 participants. The study started on 2025-09-29. Estimated completion is 2032-08.
What conditions does trial NCT06813820 study?
This clinical trial studies the following conditions: CHF, Left Ventricle Remodeling, Left Ventricle Dilated.
What interventions are being tested in trial NCT06813820?
The interventions under investigation include: Revivent System (DEVICE).
Who is sponsoring clinical trial NCT06813820?
This trial is sponsored by BioVentrix, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06813820 being conducted?
This trial has 6 study locations across Arizona, Florida, Illinois, Missouri, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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