Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923673
• Other study ID #: 18-010106
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: August 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Pericardiotomy
The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac and Cerebrovascular Events	The number of major cardiac and cerebrovascular events reported.	6 months
Primary	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	Change in Quality of Life	Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)	baseline, 6 months
Secondary	Change in exercise capacity	Measured by Cardiopulmonary Exercise Testing	baseline, 6 months

External Links

•   Mayo Clinic Clinical Trials