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

Summary

The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.

Eligibility

Inclusion Criteria:

* \>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

Exclusion Criteria:

* Recent (within three months) acute coronary syndrome
* Recent (within six months) PCI or CABG
* 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
* 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
* Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
* Patient having undergone tricuspid valve replacement or repair
* Known allergy to stainless steel or nickel
* 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

Conditions2

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