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

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

The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.

This study is a multicenter, multi-country three-arm prospective and retrospective investigation in up to 400 subjects conducted at a maximum of 40 investigational centers. Arm 1 will include eligible prospective subjects. Arm 2 will include subjects who were previously enrolled and treated with the Reducer during the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study. Arm 3 will include subjects who received a Reducer under CE Mark (unrelated to the COSIRA study).

Inclusion Criteria - ALL Arms:

• Subject has been informed about the study and provides written informed consent prior to enrollment
• Subject is willing to comply with specified follow-up evaluations

Inclusion Criteria - Arm 1:

• Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy
• Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI)
• Evidence of reversible myocardial ischemia
• Left Ventricular ejection fraction (LVEF) greater than or equal to 30%
• Male or non-pregnant female

Inclusion Criteria - Arm 2:

• Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study

Inclusion Criteria - Arm 3:

• Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study

Exclusion Criteria - Arm 1:

• 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