Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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 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)

  • 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 of 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 or legal guardian/representative to give written informed consent.

  • Additional factors deemed unsuitable for trial enrollment per discretion of the Principal Investigator

  • Inmates

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/19/2025. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amir Lerman, M.D.

Contact us for the latest status

Contact information:

Diana Albers

(507) 255-6884

Albers.Diana2@mayo.edu

More information

Publications

Publications are currently not available