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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Heart Failure with Preserved Ejection Fraction | Experimental | Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericardiotomy | Procedure | The minimally invasive procedure that creates a small opening in the sac that surrounds the heart. |
|
| 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 |
| 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 |
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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:
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:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Barry A Borlaug, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010492 | Pericardiectomy |
| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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| baseline, 6 months |