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.
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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

Steve Chartier

(925) 830-1000

schartier@bioventrix.com

CONTACT