A. Inclusion criteria | B. Exclusion criteria |
---|---|
1. Patient >18 years of age | Clinical |
2. Symptomatic CAD with chronic refractory angina pectoris classified as CCS class III or IV despite attempted optimal medical therapy for 30 days prior to screening | 1. Recent (<3 months) acute coronary syndrome |
3. Patient has limited treatment options for revascularization by CABG or PCI | 2. Recent (<6 months) successful PCI or CABG |
4. Evidence of reversible ischemia that is attributable to the left coronary arterial system by dobutamine echocardiography | 3. Recent (<1 month) unstable angina (recent onset, crescendo, or rest angina with ECG changes) |
5. Left ventricular ejection fraction >25% | 4. De-compensated CHF or hospitalization due to CHF during the 3 months prior to screening |
6. Male or nonpregnant female (NB: Females of child-bearing potential must have a negative pregnancy test) | 5. Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus |
7. Patient understands the nature of the procedure and provides written informed consent prior to enrollment | 6. Life-threatening rhythm disorders or any rhythm disorders requiring an internal defibrillator and or pacemaker |
8. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone | 7. Severe COPD as indicated by a forced expiratory volume in one second <55% of the predicted value |
8. Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina | |
9. Severe valvular heart disease | |
10. Patient having undergone tricuspid valve replacement or repair | |
11. Chronic renal failure (serum creatinine >2 mg/dL), including patients on chronic hemodyalisis | |
12. Moribund patients, or patients with comorbidities limiting life expectancy <1 year | |
13. Contraindication to required study medications that cannot be adequately controlled with premedication | |
14. Known allergy to stainless steel or nickel | |
15. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints | |
Anatomical | |
16. Mean right atrial pressure ≥_ 15 mmHg | |
17. Patient with anomalous or abnormal CS as demonstrated by angiographic abnormalities defined either: | |
a. Abnormal CS anatomy (for example, tortuosity, aberrant branch, persistent left SVC) and/or; | |
b. CS diameter at the site of planned Reducer implantation <9.5 mm or >13 mm |