Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

Mayo Clinic

Status

Completed

Conditions

Heart Failure

Treatments

Procedure: Pericardiotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03923673

18-010106

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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