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NCT07057323

Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Mayo Clinic
~35 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Coronary Sinus Reducer

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise
Measured over Baseline, 6 months

Conditions

Heart Failure Preserved Ejection Fraction

Explore related trials

Heart failure with normal ejection fraction

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Claire Raphael, M.B.B.S. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility 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 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

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

What this trial measures

  • Change in Pulmonary Arterial Wedge Pressure (PAWP) at exerciseBaseline, 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.