Back to resultsRandomized Evaluation and Verification of Ventricular Enhancement (REVIVE-HF)
Primary Purpose
Ischemic Cardiomyopathy, Heart Failure
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Revivent TC Ventricular Enhancement System
GDMT
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle.
Exclusion Criteria:
- Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities;
- Inadequate myocardial viability in regions remote from the scar.
- Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels;
- Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment;
- Patient intolerance or unwillingness to take anti-coagulation medication;
- Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;
- Pulmonary Arterial Pressure > 60 mm Hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy;
- Myocardial Infarction within 90 days prior to the procedure;
- Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement;
- Chronic renal failure with a serum creatinine >2 mg/dL;
- Inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation.
- Baseline 6-minute walk distance of >450m
Sites / Locations
- German Heart Institute Berlin and Charité University Medicine Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Revivent TC Ventricular Enhancement System plus GDMT
GDMT Only
Arm Description
Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Outcomes
Primary Outcome Measures
6 Minute Walking Distance
Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.
Secondary Outcome Measures
Quality of Life Index
Changes in Quality of Life Index measured compared to baseline using the MLHFQ Quality of Life Questionnaire.
NYHA Classification
Changes in NYHA Heart Classification compared to baseline
LVESVI and LVEDVI
Changes in left ventricular end systolic volume index (LVESVI) end diastolic volume index (LVEDVI) measured by echocardiogram compared to baseline
LVEF
Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03845127
Brief Title
Randomized Evaluation and Verification of Ventricular Enhancement
Acronym
REVIVE-HF
Official Title
Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioVentrix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone.
Detailed Description
The purpose of the study is to demonstrate that treatment with the BioVentrix Revivent TC System is more effective than guideline directed medical therapy for the treatment of ischemic heart failure. This is a prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone. This study will include 180 patients of which 120 patients will be treated with the investigational device and 60 patients will be maintained on GDMT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy, Heart Failure
Keywords
Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:1 Randomized Study Design. Crossover permitted after 6 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Revivent TC Ventricular Enhancement System plus GDMT
Arm Type
Experimental
Arm Description
Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Arm Title
GDMT Only
Arm Type
Active Comparator
Arm Description
Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Intervention Type
Device
Intervention Name(s)
Revivent TC Ventricular Enhancement System
Intervention Description
Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.
Intervention Type
Drug
Intervention Name(s)
GDMT
Intervention Description
Guideline Directed Medical Therapy
Primary Outcome Measure Information:
Title
6 Minute Walking Distance
Description
Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.
Time Frame
3 and 6 months after enrollment
Secondary Outcome Measure Information:
Title
Quality of Life Index
Description
Changes in Quality of Life Index measured compared to baseline using the MLHFQ Quality of Life Questionnaire.
Time Frame
3 and 6 months after enrollment
Title
NYHA Classification
Description
Changes in NYHA Heart Classification compared to baseline
Time Frame
3 and 6 months after enrollment
Title
LVESVI and LVEDVI
Description
Changes in left ventricular end systolic volume index (LVESVI) end diastolic volume index (LVEDVI) measured by echocardiogram compared to baseline
Time Frame
3 and 6 months after enrollment
Title
LVEF
Description
Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline
Time Frame
3 and 6 months after enrollment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle.
Exclusion Criteria:
Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities;
Inadequate myocardial viability in regions remote from the scar.
Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels;
Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment;
Patient intolerance or unwillingness to take anti-coagulation medication;
Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;
Pulmonary Arterial Pressure > 60 mm Hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy;
Myocardial Infarction within 90 days prior to the procedure;
Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement;
Chronic renal failure with a serum creatinine >2 mg/dL;
Inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation.
Baseline 6-minute walk distance of >450m
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Anker, MD
Organizational Affiliation
Berlin-Brandenburger Centrum für Regenerative Therapien (BCRT) und Medizinische Klinik m. S. Kardiologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Volkmar Falk, MD
Organizational Affiliation
Ärztlicher Direktor, Direktor der Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Heart Institute Berlin and Charité University Medicine Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Evaluation and Verification of Ventricular Enhancement
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