Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Not Applicable
Completed
- Conditions
- Heart Failure
- Interventions
- Procedure: Pericardiotomy
- Registration Number
- NCT03923673
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects with Heart Failure with Preserved Ejection Fraction Pericardiotomy Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy.
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac and Cerebrovascular Events 6 months The number of major cardiac and cerebrovascular events reported.
Change in left ventricular filling pressures during volume loading baseline, 6 months The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.
- Secondary Outcome Measures
Name Time Method Change in Quality of Life baseline, 6 months Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in exercise capacity baseline, 6 months Measured by Cardiopulmonary Exercise Testing
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States