Revivent System for Congestive Heart Failure
(RELIVE Trial)
Recruiting at 2 trial locations
SC
Overseen BySteve Chartier
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: BioVentrix
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this 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 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.
Who Is on the Research Team?
VT
Vinod THourani, MD
Principal Investigator
Piedmont Healthcare
MF
Marat Fudim, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for people with heart failure symptoms not improved by medication, a left ventricular ejection fraction below 40%, and specific types of scars in the heart. Participants must have completed certain health questionnaires, be on standard heart failure meds, consent to the study's terms, and agree to follow-up visits.Inclusion Criteria
My heart has a scar in the front or side areas, confirmed by imaging.
My heart's pumping chamber is larger than normal.
I have completed the 6 Minute Walk Test and the KCCQ Quality of Life Questionnaire.
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What Are the Treatments Tested in This Trial?
Interventions
- Revivent System
Trial Overview The RELIVE trial is testing if adding the Revivent System to usual heart failure medications (GDMT) helps more than GDMT alone. It's a study where two-thirds of patients get the new treatment and one-third don't. They'll check safety after 30 days and how well it works after 6 months and a year.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT)Experimental Treatment1 Intervention
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)
Group II: Guideline Directed Medical Therapy (GDMT) onlyActive Control1 Intervention
Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioVentrix
Lead Sponsor
Trials
8
Recruited
510+
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