This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left ventricular (LV) volume reduction in heart failure (HF).
The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the feasibility of using the BioVentrix Revivent TC System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure. The objective of this study is to determine the safety and functionality of a device that enables left ventricle (LV) volume and radius reduction through scar exclusion in appropriate patients suffering from systolic HF. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating heart, and creates the option of eliminating the use of Cardiopulmonary Bypass. The System utilizes anchors that are implanted into the scarred portion of the heart, rendering the ventricle smaller, and is employed in a cardiac surgical setting without the use of cardiopulmonary bypass. The Revivent TC anchors may be implanted through a sternotomy or through a mini-thoracotomy and jugular access. Eligible subjects will be limited to those whose ventricular dysfunction is due to ischemic cardiomyopathy caused, by a previous (greater than 90 days) myocardial infarction (MI) with acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Hospital Clinic University of Barcelona
Barcelona, Spain
Primary Safety Endpoint
Overall rate of serious adverse events (SAEs)
Time frame: 6 months
Primary Efficacy Endpoint
Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline
Time frame: 6 months
Secondary Safety Endpoint
Rate of Serious Adverse Device Effects
Time frame: 6 months
Secondary Efficacy Endpoint
Change in Left Ventricular Ejection Fraction compared to Baseline
Time frame: 6 months
Secondary Efficacy Endpoint
Hospital readmission for Heart Failure
Time frame: 6 months
Secondary Efficacy Endpoint
Change in NYHA failure class compared to Baseline
Time frame: 6 months
Secondary Efficacy Endpoint
Change in a standardized 6-minute corridor walk test compared to Baseline
Time frame: 6 months
Secondary Efficacy Endpoint
Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire compared to Baseline
Time frame: 6 months
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