Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Researchers are studying the safety and efficacy of a minimally invasive treatment called a
 pericardiotomy, which creates a small opening in the sac that surrounds the heart.
 Researchers will test the short and long term effects of this procedure by monitoring
 subjects heart function and symptoms.
Inclusion Criteria

 -  Age ≥ 30 years

 -  Symptoms of severe dyspnea (III-IV) without evidence of a non-cardiac or ischemic
 explanation for dyspnea

 -  EF of > or = 50% determined on most recent imaging study within the preceding 5 years,
 with no change in clinical status suggesting potential for deterioration in systolic
 function

 -  One of the following:

 -  Previous hospitalization for HF with radiographic evidence (pulmonary venous
 hypertension, vascular congestion, interstitial edema, pleural effusion) of
 pulmonary congestion or

 -  Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP
 ≥18) or with exercise (PCWP ≥25) or

 -  Elevated NT-proBNP (>400 pg/ml) or BNP(>200 pg/ml) or

 -  Echo evidence of diastolic dysfunction/elevated filling pressures manifest by
 medial E/e' ratio≥15 and/or left atrial enlargement and chronic treatment with a
 diuretic for signs or symptoms of heart failure

 -  Heart failure is primary factor limiting activity as indicated by answering # 2 to the
 following question: My ability to be active is most limited by:

 -  Joint, foot, leg, hip or back pain

 -  Shortness of breath and/or fatigue and/or chest pain

 -  Unsteadiness or dizziness

 -  Lifestyle, weather, or I just don't like to be active

 -  Ambulatory (not wheelchair / scooter dependent)

 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