BRAVE-TC: BioVentrix registry assessment of ventricular enhancement for the Revivent TC™ system

BioVentrix, Inc.0 个研究点目标入组 100 人开始时间: 2016年11月29日最近更新: 2016年12月19日

试验速览

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•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

•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

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