RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Recruiting
N/A
Interventional Study
Left Ventricle Remodeling
Left Ventricle Dilated
CHF
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 135 (estimated)
- Sponsor
- BioVentrix · Industry
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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 …
Trial Locations
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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…
Contacts