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Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure With A Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction

NCT07057323•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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 Criteria

•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)
+15 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

October 16, 2025

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2027

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Heart Failure Preserved Ejection Fraction

Interventions

Coronary Sinus Reducer

DEVICE

Exercise Testing After Preeclampsia

NCT06741436

PreeclampsiaHeart Failure Preserved Ejection Fraction+1 more

View study

NOT_YET_RECRUITINGPHASE4

Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction

NCT07178145

Heart Failure Preserved Ejection FractionEpicardial Adipose Tissue

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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