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RECRUITING NA

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

NCT06813820 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 135 participants
Start Date 2025-09-29
Est. Completion 2032-08
Phase NA

Sponsor

BioVentrix

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06813820

The ClinicalTrials.gov registry entry for NCT06813820 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioVentrix, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06813820 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Arizona, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06813820?

The interventions under investigation include: Revivent System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06813820?

This trial is sponsored by BioVentrix, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial