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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:
The study objectives are as follows:
Primary Endpoint:
- 1-year Canadian Cardiovascular Society (CCS) angina class
Secondary Endpoints:
The definitions for MACE events are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all cause mortality | All-cause mortality | 30 days, 1 year |
| Rates of Major Adverse Cardiovascular Events (MACE) | Defined as the incidence of cardiac-related death, myocardial infarction (Q-wave and non Q-wave), congestive heart failure, cerebrovascular accident, and serious arrhythmia. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who meet the eligibility criteria at the selected centers will be provided an opportunity to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Scott B Capps, MS | CryoLife, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic and Vascular Surgical Associates | Jacksonville | Florida | 32204 | United States | ||
| TriStar Cardiovascular Surgery |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D060050 | Angina, Stable |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 30 days, 1 year |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |