Enrolling by invitation

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

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Study Aim

This 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

Cardiovascular Diseases+1

+ Heart Diseases

+ Heart Failure

Over 18 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 16, 2025

Actual 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
NCT07057323
Principal SponsorMayo Clinic
Last updated: March 21, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart FailureHeart Failure, Diastolic

Criteria

5 inclusion criteria required to participate
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 9 months prior to enrollment. Abnormal CFR of <= 2.5
Non-Obstructive CAD ( <= 50% stenosis in epicardial vessels and/or iFR > 0.89 or FFR > 0.8 in vessels with 50 to 70% stenosis)
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25 exclusion criteria prevent from participating
History of left ventricular (LV) ejection fraction < 50%
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
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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

Secondary Objectives

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

Suspended

Mayo Clinic in Rochester

Rochester, United StatesOpen Mayo Clinic in Rochester in Google Maps
Enrolling by invitationOne Study Center