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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Subjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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.
Time frame: Baseline, 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 30 Days, 60 Days, 90 Days, 6 months
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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.
Time frame: 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.
Time frame: Baseline, 6 months
Change in transcardiac lactate release
Transcardiac lactate release will be determined by blood sample and measured in mmol/L.
Time frame: Baseline, 6 months
Change in transcardiac lactate uptake
Transcardiac lactate uptake will be determined by blood sample and measured in mmol/L.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months
Change in Right Atrial Pressure
Right Atrial Pressure is the blood pressure in the right atrium.
Time frame: Baseline, 6 months