RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

Conditions

• CHF
• Left Ventricle Dilated
• Left Ventricle Remodeling

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Revivent System — DEVICE
  BioVentrix has developed the Revivent System to mirror Surgical Ventricular Restoration (SVR). The Revivent System is used to place permanent cardiac implants to the epicardial surface for the purpose of reconfiguring abnormal cardiac geometry that is contributing to the dysfunction.

Study Details

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.

Key Dates

Start date

Sep 29, 2025

Status verified

Feb 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2032

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT)
  Medical Intervention through a mini thoracotomy, placement of anchors to plicate the scarred areas of the heart thereby reducing the left ventricle size and improving left ventricle mechanics. Subjects would continue on Guideline Directed Medical Therapy (GDMT)
• No Intervention: Guideline Directed Medical Therapy (GDMT) only
  Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention.

Primary Outcome Measure

Major Adverse Events Composite Performance Goal [ Time Frame: 30 days ]

Central Contacts

• Steve Chartier
  (925) 830-1000
  [email protected]

Locations (6)

Find similar trials in Phoenix, AZ

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