CardioGenesis Transmyocardial Revascularization 1-Year Follow-Up Study
Completed
Conditions studied: Class IV Angina
In brief
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.
Key facts
- Study ID
- NCT02694861
- Run by
- CryoLife, Inc.
- People needed
- 114
- Starts
- 2016-03-01
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2021-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- Cardiothoracic and Vascular Surgical Associates — Jacksonville, Florida, United States
- TriStar Cardiovascular Surgery — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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