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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.
Guideline Directed Medical Therapy
German Heart Institute Berlin and Charité University Medicine Berlin
Berlin, Germany
6 Minute Walking Distance
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
Quality of Life Index
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
NYHA Classification
Changes in NYHA Heart Classification compared to baseline
Time frame: 3 and 6 months after enrollment
LVESVI and LVEDVI
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
LVEF
Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline
Time frame: 3 and 6 months after enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.