Heart Failure Preserved Ejection Fraction
Conditions
Brief summary
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.
Interventions
DEVICECoronary Sinus Reducer
Subjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure.
Sponsors
Mayo Clinic
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent and willing to participate in all required study follow-up assessments * Clinical indicated coronary angiography with invasive CRT testing or PET with CRF assessment prior to enrollment. Abnormal CFR of ≤ 2.5 or PET CFR ≤ 2.0 * Symptomatic HFpEF defined by (PAWP\>15mmHg at rest and /or PAWP\>25 mmHg on exertion) during clinically performed Right heat catheterization with exercise performed prior to enrollment or during screening visit (if not performed clinically ). * Non-Obstructive CAD (≤ 50% stenosis in epicardial vessels and/or iFR\>0.89 or FFR\>0.8 in vessels with 50 to 70% stenosis)
Exclusion criteria
* Significant epicardial CAD (angiographic stenosis ≥70% or positive FFR or iFR in any major epicardial coronary artery * Significant valvular heart disease moderate to severe regurgitation and or stenosis) * Primary cardiomyopathies (hypertrophic, infiltrative or restrictive) * Constrictive pericarditis * Severe myocardial bridging * Pregnancy * Recent (with 3 months) acute coronary syndrome * Subjects in Cardiogenic shock (systolic pressure\<80mm/Hg) * Mean right atrial pressure at rest \>15 mmHg * Anomalous or abnormal CS anatomy (e.g. tortuosity aberrant branch persistent left superior vena cava as demonstrated on angiogram * CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram. * Known severe reaction to required procedural medications * Known allergy to stainless steel or nickel * Magnetic Resonance Imaging (MRI) within 8 weeks after Reducer implantation * Chronic renal failure (serum creatinine\>2mg/dL) * Severe chronic obstructive pulmonary disease (COPD) as indicated by forced expiratory volume in one second that is less than 55% of the predicted value or need for home daytime oxygen * Pacemaker electrode/lead in the coronary sinus * Moribund or with comorbidities limiting life expectancy to less than one year * Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention. * Inability or unwillingness of individual to give written informed consent. * Additional factors deemed unsuitable for trial enrollment per discretion of the Principal Investigator * Inmates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise | Baseline, 6 months | Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at 20W exercise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kansas City Cardiomyopathy (KCCQ-12) | Baseline, 30 Days, 60 Days, 90 Days, 6 months | 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. |
| Change in Seattle Angina Questionnaire (SAQ) | Baseline, 30 Days, 60 Days, 90 Days, 6 months | 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. |
| Change in New York Heart Association (NYHA) classification | Baseline, 6 months | 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. |
| Change in Canadian Cardiovascular Society (CCS) | Baseline, 30 Days, 60 Days, 90 Days, 6 months | 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. |
| Change in Borg maximal perceived exertion scores | Baseline, 6 months | 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. |
| Change in maximum exercise capacity (VO2 max) during supine exercise testing | Baseline, 6 months | 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. |
| Change in transcardiac lactate release | Baseline, 6 months | Transcardiac lactate release will be determined by blood sample and measured in mmol/L. |
| Change in transcardiac lactate uptake | Baseline, 6 months | Transcardiac lactate uptake will be determined by blood sample and measured in mmol/L. |
| Change in Pulmonary Arterial Wedge Pressure (PAWP) at rest | Baseline, 6 months | Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at rest. |
| Change in Pulmonary Arterial Pressure at rest | Baseline, 6 months | 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. |
| Change in Pulmonary Arterial Pressure at exercise | Baseline, 6 months | 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. |
| Cardiac output | Baseline, 6 months | 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. |
| Change in Right Atrial Pressure | Baseline, 6 months | Right Atrial Pressure is the blood pressure in the right atrium. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClaire Raphael, M.B.B.S.
Mayo Clinic
Outcome results
None listed