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

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ClinicalTrials.gov Identifier: NCT02553785
Recruitment Status : Unknown
Verified September 2015 by BioVentrix.
Recruitment status was:  Recruiting
First Posted : September 18, 2015
Last Update Posted : September 18, 2015
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
BioVentrix

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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: Revivent TC Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Revivent TC
Surgical treatment of left ventricle using the Revivent TC System
Device: Revivent TC



Primary Outcome Measures :
  1. Primary Safety Endpoint [ Time Frame: 6 months ]
    Overall rate of serious adverse events (SAEs)

  2. Primary Efficacy Endpoint [ Time Frame: 6 months ]
    Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline


Secondary Outcome Measures :
  1. Secondary Safety Endpoint [ Time Frame: 6 months ]
    Rate of Serious Adverse Device Effects

  2. Secondary Efficacy Endpoint [ Time Frame: 6 months ]
    Change in Left Ventricular Ejection Fraction compared to Baseline

  3. Secondary Efficacy Endpoint [ Time Frame: 6 months ]
    Hospital readmission for Heart Failure

  4. Secondary Efficacy Endpoint [ Time Frame: 6 months ]
    Change in NYHA failure class compared to Baseline

  5. Secondary Efficacy Endpoint [ Time Frame: 6 months ]
    Change in a standardized 6-minute corridor walk test compared to Baseline

  6. Secondary Efficacy Endpoint [ Time Frame: 6 months ]
    Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire compared to Baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Noel Messenger, MBA +1 925-830-1000 ext 231 nmessenger@bioventrix.com
Contact: Wendy Gries +1 925-830-1000 ext 203 wgries@bioventrix.com

Locations
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Spain
Hospital Clinic University of Barcelona Recruiting
Barcelona, Spain
Contact: Jose Pomar, MD       JLPOMAR@clinic.ub.es   
Contact: Manuel Sabate, MD         
Sponsors and Collaborators
BioVentrix
Ohio State University

Additional Information:
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Responsible Party: BioVentrix
ClinicalTrials.gov Identifier: NCT02553785     History of Changes
Other Study ID Numbers: CIP-0056
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by BioVentrix:
BioVentrix
Revivent
Revivent TC

Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases