A Multi-Center Single Arm One Year Prospective Follow-Up of Patients Treated With the CryoLife CardioGenesis Holmium:YAG Laser System for Transmyocardial Revascularization (The TMR 365 Study)
Sponsor study identifier
observational
114
1 country
2
Study Start
March 2016
Actual (reported)Primary Completion
October 2020
Actual (reported)Study Completion
October 2020
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2016
Actual (reported)March 2016
Actual (reported)March 1, 2016
Actual (reported)October 2020
Actual (reported)October 2020
Actual (reported)Change in Canadian Cardiovascular Society (CCS) Angina Class from Baseline (Class IV) at 1 Year.
Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.
1 year
Rate of all cause mortality
30 days, 1 year
Rates of Major Adverse Cardiovascular Events (MACE)
30 days, 1 year
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).
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.
All patients who meet the eligibility criteria at the selected centers will be provided an opportunity to participate.
Cardiothoracic and Vascular Surgical Associates
Jacksonville, Florida, 32204, United States
TriStar Cardiovascular Surgery
Nashville, Tennessee, 37203, United States
Scott B Capps, MS
CryoLife, Inc.
114 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2016
First Posted
March 1, 2016
Study Start
March 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 2020
Actual (reported)Study Completion
October 2020
Actual (reported)Last Updated
March 4, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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