Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Pericardiotomy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Heart Failure with Preserved Ejection Fraction<br>Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy. | Procedure: Pericardiotomy<br>* The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events | The number of major cardiac and cerebrovascular events reported. | 6 months | 
| Change in left ventricular filling pressures during volume loading | The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy. | baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ) | baseline, 6 months | 
| Change in exercise capacity | Measured by Cardiopulmonary Exercise Testing | baseline, 6 months |