Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy (ReviventTC1)

• ClinicalTrials.gov Identifier: NCT02553785
• Recruitment Status: Completed
• First Posted: September 18, 2015
• Last Update Posted: March 12, 2021
• Sponsor: BioVentrix
• Collaborator: Ohio State University
• Information provided by (Responsible Party): BioVentrix

Tracking Information

• First Submitted Date: September 15, 2015
• First Posted Date: September 18, 2015
• Last Update Posted Date: March 12, 2021
• Study Start Date: June 2015
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2015)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 16, 2015)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
• Official Title: Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
• Brief Summary: 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).

Detailed Description

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
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Heart Failure
• Intervention: Device: Revivent TC

Study Arms

Experimental: Revivent TC

Surgical treatment of left ventricle using the Revivent TC System

Intervention: Device: Revivent TC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: March 10, 2021): 89
• Original Estimated Enrollment (submitted: September 16, 2015): 50
• Actual Study Completion Date: December 2019
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age 18 - 80;
• Left Ventricular Ejection Fraction (LVEF) >15% and ≤ 45%;
• New York Heart Association (NYHA) Functional Class II-IV;
• Left Ventricular End Systolic Volume (LVESVI) ≥60 cc/m² but ≤ 120 cc/ m²
• Contiguous acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) regions of the left ventricle as evidenced by a Cardiac Magnetic Resonance (CMR) or Computed Tomography (CT);
• Maintained standard medical management for at least 90 days, and at stable target (or maximum tolerated) dosages;
• Willing and competent to complete informed consent;
• Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by CMR or CT;
• Agree to required follow-up visits

Exclusion Criteria:

• Calcified ventricular wall in the area of intended scar exclusion as verified by echocardiography or equivalent;
• Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent;
• Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment;
• Significant diastolic dysfunction, defined as a pseudo-normal Doppler filling pattern with E/A ratio > 2;
• Thin walled, paradoxically moving septal scar that would preclude successful support of the anchor pairs as evidenced by CMR;
• Cardiac valve disease which, in the opinion of the investigator, will require surgery;
• Intolerance or unwillingness to take anti-coagulation medication;
• Functioning pacemaker leads in antero-apical right ventricle, which, in the opinion of the investigator, would interfere with anchor placement;
• Pulmonary Arterial Pressure > 60 mm Hg via echo;
• Myocardial Infarction within 90 days prior to enrollment;
• Previous Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) which resulted, in the opinion of the investigator, in a significant residual neurological deficit;
• Aorto iliac disease that would preclude fem-fem bypass.
• Previous right neck surgery, previous pericardiotomy, previous left chest surgery;
• Co-morbid disease process with life expectancy of less than one year;
• Patients with lung, kidney and/or liver transplant;
• Chronic renal failure with a serum creatinine >2 mg/dL;
• Inoperable coronary disease with significant ischemia;
• Pregnant or planning to become pregnant during the study;
• Enrolled in any concurrent study other than observational.
• Previous left thoracotomy
• Pulmonary disease that would preclude single lung ventilation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02553785
• Other Study ID Numbers: CIP-0056
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: BioVentrix
• Original Responsible Party: Same as current
• Current Study Sponsor: BioVentrix
• Original Study Sponsor: Same as current
• Collaborators: Ohio State University
• Investigators: Not Provided
• PRS Account: BioVentrix
• Verification Date: March 2021