View clinical trials related to Class IV Angina.
Filter by:The purpose of this study it to collect real world 30-day and 1-year follow-up data for patients undergoing TMR with the CardioGenesis Holmium:YAG Laser System either as a sole therapy procedure or in conjunction with coronary artery bypass graft (CABG) surgery. The primary objective of this study is to provide ongoing clinical data regarding the characteristics of the patient population undergoing TMR in community practices. Secondary objectives include rates of postoperative mortality and MACE at 30-days and 1-year, and benefit of sustained improvement in angina at 30-days and 1-year. The study includes two patient populations: - Registry Group: Patients from selected centers who previously participated in the ANGINA RELIEF Registry and are eligible for a one-year, prospective follow-up; - Prospective Group: Up to 100 new, prospectively enrolled TMR patients from selected centers.
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin.
The objectives of the registry are as follows: - Track "real world" performance outcomes and physician experience using the Cardiogenesis Laser System; - Further define the disease characteristics of the population being treated; - Examine transmyocardial revascularization (TMR) usage characteristics and 30-day outcomes; - Further assess the 30-day postoperative risk factors for adverse events. To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria are to be offered the opportunity to enroll in the study at participating centers.