RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioVentrix
About this trial
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
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Revivent System
DeviceBioVentrix 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.
Treatment groups
135 Participants
are divided into 2 treatment groupsGroup A: Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT)Experimental treatment 1 intervention
Group B: Guideline Directed Medical Therapy (GDMT) onlyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 days2
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 Months3
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 Source ClinicalTrials.gov