Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

Exclusion Criteria

• •Recent (\< 1 month) hospitalization for heart failure
• •Left or right ventricular dilatation noted on cardiac imaging study prior to enrollment (either echocardiography or MRI).
• •Any hemoglobin (Hgb) \< 8.0 g/dl within 30 days prior to randomization
• •Any GFR \< 20 ml/min/1.73 m2 within 30 days prior to randomization
• •Significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator
• •Ischemia thought to contribute to dyspnea in the opinion of the investigator
• •Acute coronary syndrome within 3 months defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
• •PCI, coronary artery bypass grafting, or new biventricular pacing within past 3 months
• •Obstructive hypertrophic cardiomyopathy
• •Known infiltrative cardiomyopathy (amyloid)
• •Pericardial disease (constriction, pericarditis, tamponade)
• •Active myocarditis
• •Complex congenital heart disease
• •Active collagen vascular disease
• •Significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions)
• •Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR \> 1.7 in the absence of anticoagulation treatment
• •Terminal illness (other than HF) with expected survival of less than 1 year
• •Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
• •Inability to comply with planned study procedures
• •Pregnancy or breastfeeding mothers