At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction
In Brief
An observational study for Class IV Angina. Completed, enrolled 203 participants across 24 sites.
Detailed Summary
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.