Clinical trial NCT03845127: Randomized Evaluation and Verification of Ventricular Enhancement
Official title: Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ischemic Cardiomyopathy
Heart Failure
Keywords: Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
Lead sponsor: BioVentrix
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 Randomized Study Design. Crossover permitted after 6 months.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6 Minute Walking Distance
timeFrame: 3 and 6 months after enrollment
Secondary outcomes:
measure: Quality of Life Index
timeFrame: 3 and 6 months after enrollment
measure: NYHA Classification
timeFrame: 3 and 6 months after enrollment
measure: LVESVI and LVEDVI
timeFrame: 3 and 6 months after enrollment
measure: LVEF
timeFrame: 3 and 6 months after enrollment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: German Heart Institute Berlin and Charité University Medicine Berlin
Study officials:
affiliation: Berlin-Brandenburger Centrum für Regenerative Therapien (BCRT) und Medizinische Klinik m. S. Kardiologie
name: Stefan Anker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ärztlicher Direktor, Direktor der Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin
name: Volkmar Falk, MD
role: PRINCIPAL_INVESTIGATOR
References: