Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy

NCT02553785 | Completed Phase 1 DMC

• 1 other identifier: CIP-0056
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Keywords

BioVentrix; Revivent; Revivent TC

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Overall rate of serious adverse events (SAEs)

  6 months

• Primary Efficacy Endpoint

  Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline

  6 months

Secondary Outcomes (6)

• Secondary Safety Endpoint

  6 months

• Secondary Efficacy Endpoint

  6 months

• Secondary Efficacy Endpoint

  6 months

• Secondary Efficacy Endpoint

  6 months

• Secondary Efficacy Endpoint

  6 months

Study Arms (1)

Revivent TC

EXPERIMENTAL

Surgical treatment of left ventricle using the Revivent TC System

Device: Revivent TC

Interventions

Revivent TC DEVICE

Revivent TC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Agree to required follow-up visits

You may not qualify if:

• 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;

Sponsors & Collaborators

• BioVentrix: lead
• Ohio State University: collaborator

Study Sites (1)

Hospital Clinic University of Barcelona

Barcelona, Spain

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

ES (1)