Observational study to collect data on health improvements after mini-invasive operation with Revivent TC device to reshape the heart and reduce its volume

Completed

• Conditions: Heart failure due to ischemic cardiomyopathy; Circulatory System; Ischaemic cardiomyopathy

• Registration Number: ISRCTN89757315
• Lead Sponsor: BioVentrix, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-29
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased ventricular volume and anteroseptal or apical scar

Additional general inclusion criteria:
2. Subject is >18 years of age
3. Subject is able and willing to provide written informed consent
4. Subject is on guideline directed medical therapy (GDMT) for heart failure

Exclusion Criteria

1. Inadequate myocardial viability in regions remote from the scar
2. Thrombus or intra-ventricular mass
3. Cardiac Resynchronization Therapy (CRT)
4. Patient intolerance or unwillingness to take anti-coagulation medication
5. Functioning pacemaker leads in antero-apical RV
6. Pulmonary Arterial Pressure > 60 mm Hg
7. Myocardial Infarction less than 90 days before the procedure
8. Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement
9. Chronic renal failure with a serum creatinine >2 mg/dL
10. Inoperable coronary disease with significant ischemia
11. Pulmonary disease that would preclude transient single lung ventilation

Study & Design

• Study Type: Observational
• Study Design: Not specified