RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Recruiting
N/AInterventional Study
Left Ventricle RemodelingLeft Ventricle DilatedCHF
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
135 (estimated)
Sponsor
BioVentrix · Industry
Who this trial is looking for
This trial is looking for adults with heart failure and specific heart conditions. Participants will try a new treatment alongside standard therapy and attend follow-up visits.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have heart failure symptoms not relieved by medical therapy
I have a non-calcified scar in my heart
I have a Left Ventricular Ejection Fraction less than 40%
I have completed a 6 Minute Walk Test
I am on adequate heart failure medication
I agree to follow-up visits
I can give written consent
You may not be able to join if
I have had a heart attack in the past 90 days
I have severe heart valve disease
I need heart surgery or intervention
I have severe lung disease
I have chronic kidney failure with a GFR less than 30
I have had a stroke or brain bleed in the last six months
I am currently in another clinical trial
I have an active cancer that is not in remission
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Status
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 ven…
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
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