Left Ventricle RemodelingRELIVENCT06813820
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
A study testing Revivent System in people with Left Ventricle Remodeling and Left Ventricle Dilated, run by BioVentrix at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricle Remodeling, Left Ventricle Dilated, CHF
- What is being tested?
- Revivent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Sep 2025to Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar
- LV Aneurysm/Scar Location: Defined as a scar involving anterior, apical or anterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging)
- Left Ventricular Ejection Fraction < 40%
- Left ventricular end-systolic volume index ≥60 mL/m2
- Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy
Show all 11Show fewer
- Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can be performed at baseline visit)
- Patient is on adequate Guideline Directed Medical Therapy (GDMT)
- Subject or a legally authorized representative must provide written informed consent
- Agree to required follow-up visits
- Female subject of childbearing potential does not plan pregnancy for at least one year following the index procedure. For a female of childbearing potential, a pregnancy test must be performed with negative results known within seven days prior to index procedure
Who cannot join
- Candidates will be excluded from the study if ANY of the following conditions is present:
- Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment
- Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical)
- Mitral Regurgitation greater than moderate (>2+)
- Need for coronary revascularization, in the opinion of the investigator
- Peak Systolic Pulmonary Arterial Pressure > 70 mm Hg via echo or right heart catheterization
Show all 13Show fewer
- Myocardial Infarction within 90 days prior to enrollment
- Within the last six months, a prior CVA or TIA, or intracranial hemorrhage
- Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission
- Severe pulmonary disease that would preclude general anesthesia
- Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac
- Chronic renal failure with a GFR<30ml/min
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Ian Merritt, 773-702-1096, ian.merritt@bsd.uchicago.edu
Christopher Salerno, MD
- Recruiting
Penn State Health
Hershey, Pennsylvania, 717033
Lisa Fox, BSN, RN, 717-531-1468, lfox5@pennstatehealth.psu.edu
- Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64131
Amanda Huffman, RB, BSN, 816-932-0391, ahuffman@saint-lukes.org
- Recruiting
Baptist Health South Florida
Miami, Florida, 33143
Kenia Sr. Nurse Research Coordinator, BSN, RN, CCRC, 786-594-9408, kenia@baptisthealth.net
Masaki Nakamura, MD
- Recruiting
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Debby Schommer, RN, CCRC, 405-608-1286, dschommer@okheart.com
- Recruiting
Banner University Medical Center
Phoenix, Arizona, 85012
Abisola Akinbobola, 602-857-2052, abisola.akinbobola@bannerhealth.com
Radha Gopalan, MD
About this study
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.
Read the detailed description
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).
- Conditions
- Left Ventricle Remodeling, Left Ventricle Dilated, CHF
- Being tested
- Revivent System
- Keywords
- Left Ventricle Reverse remodeling
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revivent SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT) | Experimental | 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) Receives: Device: Revivent System |
| Guideline Directed Medical Therapy (GDMT) only | No intervention | Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start29 Sep 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricle RemodelingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioVentrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinod THourani, MD, Principal investigator, Piedmont HealthcareMarat Fudim, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813820
- Sponsor's protocol ID
- CIP-0100
- Acronym
- RELIVE
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
- ClinicalTrials.gov ID
- NCT06813820
- Acronym / sponsor ID
- RELIVE / CIP-0100
- Conditions
- Left Ventricle Remodeling, Left Ventricle Dilated, CHF
- Keywords
- Left Ventricle Reverse remodeling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- BioVentrixIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT) | Experimental | Device: Revivent SystemMedical 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) |
| Guideline Directed Medical Therapy (GDMT) only | No intervention | –Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years old or older
- LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar
- LV Aneurysm/Scar Location: Defined as a scar involving anterior, apical or anterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging)
- Left Ventricular Ejection Fraction < 40%
- Left ventricular end-systolic volume index ≥60 mL/m2
Key exclusion criteria (13 listed)
- Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment
- Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical)
- Mitral Regurgitation greater than moderate (>2+)
- Need for coronary revascularization, in the opinion of the investigator
- Peak Systolic Pulmonary Arterial Pressure > 70 mm Hg via echo or right heart catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revivent SystemBioVentrix 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. | Device | Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT) |
Primary outcome
Major Adverse Events Composite Performance Goal
Time frame: 30 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 Endpoint
Time frame: 6 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 Endpoint
Time frame: 12 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Related trials for Left Ventricle Remodeling
Active, not recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Heart Failure, Left Ventricular Dysfunction
RecruitingPhase 4
STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure
Heart Failure With Reduced Ejection Fraction, Heart Failure
RecruitingObservational study
Cold-Region Exposure and Cardiac Remodeling After PCI
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Congestive Heart Failure
Enrolling by invitationObservational study
EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study
Abdominal Aortic Aneurysm, Arterial Stiffness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinod THourani, MD principal investigator
Piedmont Healthcare
Marat Fudim, MD principal investigator
Duke University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revivent System in people with Left Ventricle Remodeling and Left Ventricle Dilated, run by BioVentrix at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steve Chartier ((925) 830-1000 ext. 201, schartier@bioventrix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events Composite Performance Goal (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.