NCT06813820 RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
| NCT ID | NCT06813820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BioVentrix |
| Condition | Left Ventricle Remodeling |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2025-09-29 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. 18 years old or older 2. LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar 3. 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) 4. Left Ventricular Ejection Fraction \< 40% 5. Left ventricular end-systolic volume index ≥60 mL/m2 6. Suffering from heart failure symptoms as defined by NYHA Classification \> 2 not responsive to medical therapy 7. Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can be performed at baseline visit) 8. Patient is on adequate Guideline Directed Medical Therapy (GDMT) 9. Subject or a legally authorized representative must provide written informed consent 10. Agree to required follow-up visits 11. 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 Exclusion Criteria: Candidates will be excluded from the study if ANY of the following conditions is present: 1. Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment 2. Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical) 3. Mitral Regurgitation greater than moderate (\>2+) 4. Need for coronary revascularization, in the opinion of the investigator 5. Peak Systolic Pulmonary Arterial Pressure \> 70 mm Hg via echo or right heart catheterization 6. Myocardial Infarction within 90 days prior to enrollment 7. Within the last six months, a prior CVA or TIA, or intracranial hemorrhage 8. Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission 9. Severe pulmonary disease that would preclude general anesthesia 10. Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac 11. Chronic renal failure with a GFR\<30ml/min 12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
Contact & Investigator
Vinod THourani, MD
PRINCIPAL INVESTIGATOR
Piedmont Healthcare
Frequently Asked Questions
Who can join the NCT06813820 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Left Ventricle Remodeling. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06813820 currently recruiting?
Yes, NCT06813820 is actively recruiting participants. Contact the research team at schartier@bioventrix.com for enrollment information.
Where is the NCT06813820 trial being conducted?
This trial is being conducted at Phoenix, United States, Miami, United States, Chicago, United States, Kansas City, United States and 2 additional locations.
Who is sponsoring the NCT06813820 clinical trial?
NCT06813820 is sponsored by BioVentrix. The principal investigator is Vinod THourani, MD at Piedmont Healthcare. The trial plans to enroll 135 participants.