Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Heart Failure Preserved Ejection Fraction

• Registration Number: NCT07057323
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Study Start: 2025-08-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States