Randomized Evaluation and Verification of Ventricular Enhancement

Heart Failure Clinical Trial

— REVIVE-HF  

Official title:

Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03845127
• Other study ID #: CIP-0080
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: BioVentrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemic Cardiomyopathy

Intervention

Device:
• Revivent 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.

Drug:
• GDMT
Guideline Directed Medical Therapy

Locations

Country	Name	City	State
Germany	German Heart Institute Berlin and Charité University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
BioVentrix

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walking Distance	Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.	3 and 6 months after enrollment
Secondary	Quality of Life Index	Changes in Quality of Life Index measured compared to baseline using the MLHFQ Quality of Life Questionnaire.	3 and 6 months after enrollment
Secondary	NYHA Classification	Changes in NYHA Heart Classification compared to baseline	3 and 6 months after enrollment
Secondary	LVESVI and LVEDVI	Changes in left ventricular end systolic volume index (LVESVI) end diastolic volume index (LVEDVI) measured by echocardiogram compared to baseline	3 and 6 months after enrollment
Secondary	LVEF	Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline	3 and 6 months after enrollment