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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Revivent TC
Sponsored by
BioVentrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring BioVentrix, Revivent, Revivent TC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinic University of Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Revivent TC

Arm Description

Surgical treatment of left ventricle using the Revivent TC System

Outcomes

Primary Outcome Measures

Primary Safety Endpoint
Overall rate of serious adverse events (SAEs)
Primary Efficacy Endpoint
Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline

Secondary Outcome Measures

Secondary Safety Endpoint
Rate of Serious Adverse Device Effects
Secondary Efficacy Endpoint
Change in Left Ventricular Ejection Fraction compared to Baseline
Secondary Efficacy Endpoint
Hospital readmission for Heart Failure
Secondary Efficacy Endpoint
Change in NYHA failure class compared to Baseline
Secondary Efficacy Endpoint
Change in a standardized 6-minute corridor walk test compared to Baseline
Secondary Efficacy Endpoint
Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire compared to Baseline

Full Information

First Posted
September 15, 2015
Last Updated
March 10, 2021
Sponsor
BioVentrix
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT02553785
Brief Title
Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
Acronym
ReviventTC1
Official Title
Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioVentrix
Collaborators
Ohio State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
BioVentrix, Revivent, Revivent TC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Revivent TC
Arm Type
Experimental
Arm Description
Surgical treatment of left ventricle using the Revivent TC System
Intervention Type
Device
Intervention Name(s)
Revivent TC
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
Overall rate of serious adverse events (SAEs)
Time Frame
6 months
Title
Primary Efficacy Endpoint
Description
Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoint
Description
Rate of Serious Adverse Device Effects
Time Frame
6 months
Title
Secondary Efficacy Endpoint
Description
Change in Left Ventricular Ejection Fraction compared to Baseline
Time Frame
6 months
Title
Secondary Efficacy Endpoint
Description
Hospital readmission for Heart Failure
Time Frame
6 months
Title
Secondary Efficacy Endpoint
Description
Change in NYHA failure class compared to Baseline
Time Frame
6 months
Title
Secondary Efficacy Endpoint
Description
Change in a standardized 6-minute corridor walk test compared to Baseline
Time Frame
6 months
Title
Secondary Efficacy Endpoint
Description
Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire compared to Baseline
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Clinic University of Barcelona
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.bioventrix.com
Description
Sponsor Website

Learn more about this trial

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

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