ISRCTN89757315CompletedNot Applicable
BRAVE-TC: BioVentrix registry assessment of ventricular enhancement for the Revivent TC™ system
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- BioVentrix, Inc.
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
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
Investigators
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