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| Name | Class |
|---|---|
| Shockwave Medical, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, specifically invasive measurement of PAWP during standardized exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure with a preserved ejection fraction (HFpEF) | Experimental | Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Sinus Reducer | Device | Subjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise | Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at 20W exercise. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kansas City Cardiomyopathy (KCCQ-12) | KCCQ is a 12-item questionnaires that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. Scores were generated for each domain and scaled from 0 to 70, with 0 (worst) and 70 (the best possible status), where the higher score reflected better health status. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Claire Raphael, M.B.B.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline, 30 Days, 60 Days, 90 Days, 6 months |
| Change in Seattle Angina Questionnaire (SAQ) | Seattle Angina Questionnaire (SAQ) is a 19-item questionnaire that assesses 5 different scales: physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception. A higher score indicates a worse health status. | Baseline, 30 Days, 60 Days, 90 Days, 6 months |
| Change in New York Heart Association (NYHA) classification | New York Heart Association (NYHA) classification is used to classify patients into 4 categories based on their Heart Failure Symptoms. There are 4 classifications (1-4), a higher classification indicates a higher severity of Heart Failure symptoms. | Baseline, 6 months |
| Change in Canadian Cardiovascular Society (CCS) | Canadian Cardiovascular Society (CCS) is a classification system (1-4) used to determine severity of angina pectoris. A higher classification indicates higher severity of angina pectoris. | Baseline, 30 Days, 60 Days, 90 Days, 6 months |
| Change in Borg maximal perceived exertion scores | Borg CR10 Scale is a scale that ranges from 0-12. It is used to determine maximal perceived exertion. This will be measured at exercise during a right heart catheterization. | Baseline, 6 months |
| Change in maximum exercise capacity (VO2 max) during supine exercise testing | Maximum exercise capacity (VO2 max) is the maximum oxygen absorbed during exercise. VO2 max will be determined at exercise during right heart catheterization and measured in ml/kg/min. | Baseline, 6 months |
| Change in transcardiac lactate release | Transcardiac lactate release will be determined by blood sample and measured in mmol/L. | Baseline, 6 months |
| Change in transcardiac lactate uptake | Transcardiac lactate uptake will be determined by blood sample and measured in mmol/L. | Baseline, 6 months |
| Change in Pulmonary Arterial Wedge Pressure (PAWP) at rest | Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at rest. | Baseline, 6 months |
| Change in Pulmonary Arterial Pressure at rest | Pulmonary Arterial Pressure is the measure of pressure that the heart uses to pump blood from the heart to the lungs. Pulmonary Arterial Pressure will be determined by a right heart catheterization at rest and measured in mmHg. | Baseline, 6 months |
| Change in Pulmonary Arterial Pressure at exercise | Pulmonary Arterial Pressure is the measure of pressure that the heart uses to pump blood from the heart to the lungs. Pulmonary Arterial Pressure will be determined by a right heart catheterization at exercise and measured in mmHg. | Baseline, 6 months |
| Cardiac output | Cardiac output (L/min) is the total volume of blood moved by the heart per minute. Cardiac output is measured during right heart catheterization at exercise using the Fick method. | Baseline, 6 months |
| Change in Right Atrial Pressure | Right Atrial Pressure is the blood pressure in the right atrium. | Baseline, 6 months |