Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

Prior treatment

• Known severe reaction to required procedural medications

Other illness

• Significant valvular heart disease moderate to severe regurgitation and or stenosis)
• Severe myocardial bridging
• Recent (with 3 months) acute coronary syndrome
• Known allergy to stainless steel or nickel
• 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

Lab values

• Chronic renal failure (serum creatinine\>2mg/dL)

Other

• Significant epicardial CAD (angiographic stenosis ≥70% or positive FFR or iFR in any major epicardial coronary artery
• Primary cardiomyopathies (hypertrophic, infiltrative or restrictive)
• Constrictive pericarditis
• Pregnancy
• Subjects in Cardiogenic shock (systolic pressure\<80mm/Hg)
• 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.
• Magnetic Resonance Imaging (MRI) within 8 weeks after Reducer implantation
• 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

• 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 or PET with CRF assessment prior to enrollment. Abnormal CFR of ≤ 2.5 or PET CFR ≤ 2.0
• Symptomatic HFpEF defined by (PAWP\>15mmHg at rest and /or PAWP\>25 mmHg on exertion) during clinically performed Right heat catheterization with exercise performed prior to enrollment or during screening visit (if not performed clinically ).
• Non-Obstructive CAD (≤ 50% stenosis in epicardial vessels and/or iFR\>0.89 or FFR\>0.8 in vessels with 50 to 70% stenosis)