Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization

Korábbi kezelés

• Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
• De-compensated congestive heart failure or hospitalization due to CHF during the three months prior to screening

Más betegség

• Recent (within three months) acute coronary syndrome
• Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
• Severe chronic obstructive pulmonary disease as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
• Severe valvular heart disease
• Known allergy to stainless steel or nickel

Egyéb

• Recent (within six months) PCI or CABG
• Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
• Patient having undergone tricuspid valve replacement or repair
• Patient with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as: Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and/or; CS diameter at the site of implantation> 12mm

• >18 years old
• Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
• Non-candidate for surgical or percutaneous coronary intervention, as determined by 2 independent Professors of Internal medicine
• Reversible ischemia of the left ventricular wall demonstrated by Dobutamine Stress Echocardiography (Dobutamine ECHO; DSE), or by Thallium Spect