Heart Failure, Ischemic Cardiomyopathy
Conditions
Keywords
Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
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.
Interventions
DEVICERevivent TC Ventricular Enhancement System
Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.
DRUGGDMT
Guideline Directed Medical Therapy
Sponsors
BioVentrix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2:1 Randomized Study Design. Crossover permitted after 6 months.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walking Distance | 3 and 6 months after enrollment | Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Index | 3 and 6 months after enrollment | Changes in Quality of Life Index measured compared to baseline using the MLHFQ Quality of Life Questionnaire. |
| NYHA Classification | 3 and 6 months after enrollment | Changes in NYHA Heart Classification compared to baseline |
| LVESVI and LVEDVI | 3 and 6 months after enrollment | Changes in left ventricular end systolic volume index (LVESVI) end diastolic volume index (LVEDVI) measured by echocardiogram compared to baseline |
| LVEF | 3 and 6 months after enrollment | Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline |
Countries
Germany
Outcome results
None listed