CardioGenesis Transmyocardial Revascularization 1-Year Follow-Up Study
Raktažodžiai
Santrauka
apibūdinimas
The study objectives 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, including surgical procedure information, and 30-day and 1-year outcomes;
- Further assess the risk factors for adverse events at 30-days and 1-year;
- Further define MACE rates and angina scores at 30-days and 1-year. To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria will be offered the opportunity to enroll in the study at participating centers.
Primary Endpoint:
- 1-year Canadian Cardiovascular Society (CCS) angina class
Secondary Endpoints:
- All-cause mortality at 30-day and 1-year.
- Rates of major adverse cardiovascular events (MACE) at 30-days and 1-year, defined as the incidence of cardiac-related death, myocardial infarction (Q-wave and non Q-wave), congestive heart failure, cerebrovascular accident, and serious arrhythmia.
The definitions for MACE events are as follows:
- Cardiac-related death: any death that is not clearly attributable to a non-cardiac cause, and includes death due to any of the following: acute myocardial infarction, heart failure, cardiogenic shock, pulmonary edema, cardiac tamponade, arrhythmia, or post-procedural complications (i.e., bleeding).
- Q-wave myocardial infarction: the appearance of new Q waves of 40 or more milliseconds in 2 or more contiguous leads and elevation of CK-MB.
- Non Q-wave myocardial infarction: the elevation of total CK more than twice normal with elevated CK-MB.
- Congestive heart failure: Symptoms of pulmonary vascular congestion or a low output state that is due to left ventricular failure and is new in onset or results in re-hospitalization.
- Cerebrovascular accident: Any sudden development of neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, or thrombosis that persists for > 24 hours.
- Serious arrhythmia: Supra-ventricular or ventricular arrhythmias that require sustained intravenous pharmacologic treatment, temporary or permanent pacing, or immediate electrical cardioversion or defibrillation. Arrhythmias resulting in syncope, myocardial ischemia, or death are also classified as serious.
- Any other serious operative complications related to the procedure: example: major bleeding requiring transfusion.
Datos
| Paskutinį kartą patikrinta: | 08/31/2018 |
| Pirmasis pateikimas: | 02/21/2016 |
| Numatytas registravimas pateiktas: | 02/23/2016 |
| Pirmas paskelbtas: | 02/29/2016 |
| Paskutinis atnaujinimas pateiktas: | 09/13/2018 |
| Paskutinis atnaujinimas paskelbtas: | 09/16/2018 |
| Faktinė studijų pradžios data: | 02/29/2016 |
| Numatoma pirminio užbaigimo data: | 04/30/2018 |
| Numatoma studijų užbaigimo data: | 08/31/2019 |
Būklė ar liga
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Registry Group Patients previously enrolled in the ANGINA RELIEF Registry who are eligible for a 1-year, prospective follow-up (date of ANGINA RELIEF Registry TMR procedure performed within 12-18 month follow-up window). | |
| Prospective Group A group of up to 100 new, prospectively enrolled patients from active centers that receive TMR with the CardioGenesis Laser System and complete a 30-day and 1-year follow-up. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Mėginių ėmimo metodas | Non-Probability Sample |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Registry Group: Previously enrolled in the ANGINA RELIEF Registry; Eligible for a 1-year prospective follow-up (date of TMR procedure performed within 12-18 month follow-up window). - Prospective Group: Received TMR with the CardioGenesis Laser System; Class IV angina (according to Canadian Cardiovascular Society Angina Scale) prior to TMR; 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: - Registry Group: Date of ANGINA RELIEF Registry TMR procedure performed outside 1-year (12-18 month) follow-up window. - Prospective Group: Age less than 18 years; Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours). |
Rezultatas
Pirminės rezultatų priemonės
1. Change in Canadian Cardiovascular Society (CCS) Angina Class from Baseline (Class IV) at 1 Year. [1 year]
Antrinės rezultatų priemonės
1. Rate of all cause mortality [30 days, 1 year]
2. Rates of Major Adverse Cardiovascular Events (MACE) [30 days, 1 year]
