REDUCER-I: An Observational Study of the Neovasc Reducer™ System

Exclusion Criteria

• •Acute coronary syndrome within three months prior to enrollment
• •Recent successful revascularization by PCI or CABG within six months prior to enrollment
• •Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment
• •Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram \[ECG\] changes) during the 30 days prior to enrollment
• •Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment
• •Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
• •Subject cannot undergo exercise tolerance test
• •Subject cannot undergo 6-minute walk test
• •Severe valvular heart disease
• •Subject with pacemaker electrode in the coronary sinus (CS)
• •Subject with recent placement of a new pacemaker or defibrillator electrode in the right atrium within 3 months prior to enrollment.
• •Subject having undergone tricuspid valve replacement or repair
• •Chronic renal failure (serum creatinine \>2 mg/dL), including subjects on chronic hemodialysis
• •Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year
• •Known severe reaction to required procedural medications
• •Known allergy to stainless steel or nickel
• •Magnetic Resonance Imaging (MRI) planned within 8 weeks after Reducer implantation
• •Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• •Angiographic Exclusion:
• •Mean right atrial pressure greater than 15mmHg
• •Subject with anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \[SVC\])
• •CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm