- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02553785
Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy (ReviventTC1)
Study Overview
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
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Barcelona, Spain
- Hospital Clinic University of Barcelona
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Revivent TC
Surgical treatment of left ventricle using the Revivent TC System
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Safety Endpoint
Time Frame: 6 months
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Overall rate of serious adverse events (SAEs)
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6 months
|
Primary Efficacy Endpoint
Time Frame: 6 months
|
Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline
|
6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Safety Endpoint
Time Frame: 6 months
|
Rate of Serious Adverse Device Effects
|
6 months
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Secondary Efficacy Endpoint
Time Frame: 6 months
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Change in Left Ventricular Ejection Fraction compared to Baseline
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6 months
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Secondary Efficacy Endpoint
Time Frame: 6 months
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Hospital readmission for Heart Failure
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6 months
|
Secondary Efficacy Endpoint
Time Frame: 6 months
|
Change in NYHA failure class compared to Baseline
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6 months
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Secondary Efficacy Endpoint
Time Frame: 6 months
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Change in a standardized 6-minute corridor walk test compared to Baseline
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6 months
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Secondary Efficacy Endpoint
Time Frame: 6 months
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Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire compared to Baseline
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-0056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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