RELIVE Trial for Left Ventricle Remodeling and Heart Failure
This study is testing the safety and effectiveness of the BioVentrix Revivent System for people with heart failure caused by a weakened and enlarged left ventricle (the main pumping chamber of your heart). The Revivent System is a device designed to reshape the heart by placing small implants on its outer surface. This system aims to improve how your heart pumps blood. We are comparing the Revivent System plus standard medical care to standard medical care alone. To join, you must be 18 or older and have a specific type of scar or aneurysm (a bulge) in your left ventricle. The study will look at safety after 30 days and how well the treatment works after 6 and 12 months. The current status of this study is unclear.
- Study design
- This is a randomized study comparing the Revivent System plus standard medical care to standard medical care alone. About 135 participants will be enrolled, with more receiving the Revivent System.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for at least 30 days, and for effectiveness for 6 months and 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
At a glance
Conditions
NCT06813820
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Banner University Medical Center
Phoenix, Arizonastudy coordinator listed
Recruiting
Baptist Health South Florida
Miami, Floridastudy coordinator listed
Recruiting
Oklahoma Heart Hospital
Oklahoma City, Oklahomastudy coordinator listed
Recruiting
Penn State Health
Hershey, Pennsylvaniastudy coordinator listed
Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouristudy coordinator listed
Recruiting
University of Chicago
Chicago, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Vinod THourani, MD · PRINCIPAL_INVESTIGATOR · Piedmont Healthcare
- Marat Fudim, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Major Adverse Events Composite Performance Goal30 days
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)
- Composite Effectiveness Endpoint6 Months
Using Finkelstein Schoenfeld (FS) hierarchical approach. This approach compares each treatment subject versus each control subject in a hierarchal fashion beginning with Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio.
- Composite Effectiveness Endpoint12 Months
Using Finkelstein Schoenfeld (FS) hierarchical approach - Cardiovascular Mortality, Heart Transplant, Left Ventricular Assist Device (LVAD) Implantation, Hospital Readmission, Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio.