Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy (ReviventTC1)
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|ClinicalTrials.gov Identifier: NCT02553785|
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : March 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Revivent TC||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
Experimental: Revivent TC
Surgical treatment of left ventricle using the Revivent TC System
Device: Revivent TC
- Primary Safety Endpoint [ Time Frame: 6 months ]Overall rate of serious adverse events (SAEs)
- Primary Efficacy Endpoint [ Time Frame: 6 months ]Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline
- Secondary Safety Endpoint [ Time Frame: 6 months ]Rate of Serious Adverse Device Effects
- Secondary Efficacy Endpoint [ Time Frame: 6 months ]Change in Left Ventricular Ejection Fraction compared to Baseline
- Secondary Efficacy Endpoint [ Time Frame: 6 months ]Hospital readmission for Heart Failure
- Secondary Efficacy Endpoint [ Time Frame: 6 months ]Change in NYHA failure class compared to Baseline
- Secondary Efficacy Endpoint [ Time Frame: 6 months ]Change in a standardized 6-minute corridor walk test compared to Baseline
- Secondary Efficacy Endpoint [ Time Frame: 6 months ]Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire compared to Baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553785
|Hospital Clinic University of Barcelona|