An interventional study of Revivent System in Left Ventricle Remodeling, Left Ventricle Dilated and CHF, sponsored by BioVentrix. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by BioVentrix · Not applicable, Interventional, and Treatment
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.
The purpose of the study is to assess the safety and effectiveness of the BioVentrix Revivent System plus GDMT compared to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure.
Safety will be assessed compared with a Performance Goal based on surgical ventriculoplasty outcomes (MAE's at 30 days).
105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.
This study's planned enrollment of 135 is above the median of 81 across 72 interventional studies indexed under Ventricular Remodeling.
Browse Ventricular Remodeling studies →BioVentrix is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Candidates will be excluded from the study if ANY of the following conditions is present:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Device: Revivent System
Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention.
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.
Major Adverse Events Composite Performance Goal
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)
Time frame: 30 days
Composite Effectiveness Endpoint
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.
Time frame: 6 Months
Composite Effectiveness Endpoint
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.
Time frame: 12 Months
Started Sep 2025 (actual). Primary completion is estimated for Aug 2028, 35 months after the start.
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