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).

Eligibility Criteria:
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