N/A
Completed N=203
Cardiogenesis Transmyocardial Revascularization Registry
Class IV Angina
Source: ClinicalTrials.gov NCT01827319 ↗
Enrolled (actual)
203
Serious AEs
9.5%
Results posted
Aug 2016
Primary outcomePrimary: All Cause Mortality — 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause Mortality |
1 | — |
| SECONDARY Major Adverse Cardiovascular Events (MACE) Rate, Defined as the Incidence of Cardiac-related Death, Myocardial Infarction (Q-wave and Non Q-wave), Congestive Heart Failure, Cerebrovascular Accident, and Serious Arrhythmia |
19 | — |
| SECONDARY 2 CCS Angina Class Reduction |
183 | — |
Eligibility Criteria
Inclusion Criteria
- Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
- Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA)
Exclusion Criteria
- Age less than18 years
- Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)
Data sourced from ClinicalTrials.gov (NCT01827319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.