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).
Study Type
OBSERVATIONAL
Enrollment
400
An aid in the management of chronic refractory angina pectoris
University of Graz
Graz, Austria
Reduction in Canadian Cardiovascular Society (CCS) Grade
The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade, at 6 months as compared to baseline
Time frame: 6 Months
Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s
The rate of occurrence of device and / or procedure-related periprocedural SAEs defined as a composite of death, Myocardial Infarction (MI), cardiac tamponade, clinically-driven re-dilation of a Reducer, life-threatening arrhythmias (Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF)), and respiratory failure through 30 days post-implant
Time frame: 30 days post implant
Occurrence of Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30-days post-implant
Time frame: 30 days post implant
Reduction in Canadian Cardiovascular Society (CCS) Grade
The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade at 12 months and annually through 5 years post implant as compared to baseline
Time frame: 12 months and annually through 5 years
Occurrence of Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI at 6 months, 12 months and annually through 5 years post implant
Time frame: 6 months, 12 months, and annually through 5 years
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