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Coronary Sinus Reducer for Symptomatic Heart Failure with Preserved Ejection Fraction and Coronary Microvascular Dysfunction Treatment

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Study AimThis study explores if a Coronary Sinus Reducer can improve symptoms of heart failure with preserved ejection fraction and coronary microvascular dysfunction by changing pulmonary arterial wedge pressure during exercise.
What is being tested

Coronary Sinus Reducer

Device
Who is being recruted

Heart Failure Preserved Ejection Fraction

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorMayo Clinic
Study ContactDiana Albers
Last updated: September 15, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual date on which the first participant was enrolled.

This study focuses on evaluating a treatment device called the CS Reducer for people who have a type of heart failure known as HFpEF, which means heart failure with preserved ejection fraction. These individuals also experience coronary microvascular dysfunction, a condition affecting the small blood vessels in the heart. The goal is to see if the CS Reducer can help manage symptoms by reducing the pressure in the heart, especially during exercise. This could be important for improving quality of life and managing symptoms in patients who currently have limited treatment options. Participants in the study will have the CS Reducer implanted, and its effects will be monitored through specialized tests that measure the pressure inside the heart, particularly the pulmonary artery wedge pressure (PAWP), while exercising. This procedure involves an invasive measurement, meaning it directly assesses what's happening inside the heart. The study does not mention specific risks or benefits, but the potential benefit is better management of heart symptoms during physical activity.

Official TitleCoronary Sinus Reducer For The Management Of Symptomatic Heart Failure With A Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction 
Principal SponsorMayo Clinic
Study ContactDiana Albers
Last updated: September 15, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
35 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Heart Failure Preserved Ejection Fraction
Criteria

Inclusion: * Age ≥ 18 * 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 within 6 months prior to enrollment. Abnormal CFR of ≤ 2.5 * Symptomatic HFpEF defined by (PAWP\>15mmHg at rest and /or PAWP\>25 mmHg on exertion) during clinically performed Right heat catheterization with exercise performed within 6 months of enrollment or during screening visit (if not performed clinically in the last 6 months). * 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: * History of left ventricular (LV) ejection fraction \<50% * Significant epicardial CAD (angiographic stenosis ≥70% or positive FFR or iFR in any major epicardial coronary artery * Significant valvular heart disease (more than moderate regurgitation and or stenosis) * Primary cardiomyopathies (hypertrophic, infiltrative or restrictive) * Constrictive pericarditis * Severe myocardial bridging * Stiff left atrial syndrome * Pregnancy * Recent (with 3 months) acute coronary syndrome * Subjects in Cardiogenic shock (systolic pressure\<80mm/Hg) * NYHA Class III or IV heart failure decompensated HF * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD.
Study Objectives
Primary Objectives

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 Objectives

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.

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.

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.

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.

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.

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.

Transcardiac lactate release will be determined by blood sample and measured in mmol/L.

Transcardiac lactate uptake will be determined by blood sample and measured in mmol/L.

Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization 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.

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 (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.

Right Atrial Pressure is the blood pressure in the right atrium.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Mayo Clinic in RochesterRochester, United StatesSee the location
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One Study Center