Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

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)
• 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