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The objectives of the registry are as follows:
The objectives of this patient registry, which collects data on the Cardiogenesis Laser System, include: provide further information on the disease characteristics of the population being treated, examine TMR usage characteristics, monitor 30-day postoperative mortality and MACE rates, and assess preoperative and operative 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. Patient consent indicates approval to allow collection of their confidential data; nonetheless, their identity will not be disclosed in any publication of this study.
The primary endpoint to be assessed in this study is:
• All-cause 30-day mortality
Additional endpoints to be assessed in this study are:
• 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 in the 30-day postoperative period.
The definitions for these 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: Supraventricular 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.
Each contributing site is required to complete the Enrollment Failure Log Form for all patients undergoing TMR, but not enrolled into the registry due to inclusion/exclusion criteria failure or did not consent for registry participation. If the decision to perform TMR is done intra-operatively, the patient will be approached for participation in the registry after the procedure. No data should be collected prior to patient consent to take part in the registry.
All data collected must be supported by source documents found at the site. Patient medical records, hospital charts, operative reports, laboratory and diagnostic testing results, office visits, source document worksheets as supplied by the Sponsor, etc. will be utilized for collection of relevant data. All data is subject to 100% source document review by Sponsor personnel and/or a representative of the Sponsor at Sponsor's discretion.
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| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | Number of Participant Deaths | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days | |
| 2 CCS Angina Class Reduction |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who meet the eligibility criteria and undergo TMR at the selected centers will be provided an opportunity to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Scott Capps, MS | CryoLife, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tuscon | Arizona | 85722 | United States | ||
| California Cardiac Surgeons |
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| ID | Title | Description |
|---|---|---|
| FG000 | Received TMR and Enrolled in ANGINA RELIEF Registry |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Canadian Cardiovascular Society (CCS) Angina Class-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.
| 30 days |
| Bakersfield |
| California |
| 93301 |
| United States |
| The Vo Group | Fountain Valley | California | 92708 | United States |
| Hurwitz & Roberts Med Corp | Glendale | California | 91204 | United States |
| Advanced Cardiothoracic Surgery Medical Group | Los Angeles | California | 90017 | United States |
| Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group | Northridge | California | 91325 | United States |
| Cardiovascular & Thoracic Surgeons of Ventura County, APC | Oxnard | California | 93030 | United States |
| Joseph W. Wilson, MD, Inc. | Rancho Mirage | California | 92270 | United States |
| Sutter Institute for Medical Research | Sacramento | California | 95819 | United States |
| Bethesda Memorial Hospital | Boynton Beach | Florida | 33435 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Cardiothoracic and Vascular Surgical Associates | Jacksonville | Florida | 32207 | United States |
| Coastal Cardiovascular and Thoracic Associates, PA | Ormond Beach | Florida | 32174 | United States |
| Georgia Health Sciences University Research Institute, Inc. | Augusta | Georgia | 30912- | United States |
| Lexington Cardiac Research Foundation, Inc. | Lexington | Kentucky | 40503 | United States |
| Owensboro Health, Inc. | Owensboro | Kentucky | 42303 | United States |
| Regional Heart & Lung Surgery | Paducah | Kentucky | 42003 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| The Feinstein Institute for Medical Research | New York | New York | 10075 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| East Tennessee Cardiovascular Surgery Group | Knoxville | Tennessee | 37923 | United States |
| Tristar Cardiovascular Surgery | Nashville | Tennessee | 37203 | United States |
| Cardiopulmonary Research Science and Technology Institute | Dallas | Texas | 75230 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Received TMR and Enrolled in ANGINA RELIEF Registry |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All Cause Mortality | Number of Participant Deaths | Posted | Number | participants | 30 days |
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| 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 | Posted | Number | participants | 30 days |
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| Secondary | 2 CCS Angina Class Reduction | Canadian Cardiovascular Society (CCS) Angina Class-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. | Posted | Number | participants | 30 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Received TMR and Enrolled in ANGINA RELIEF Registry | 19 | 200 | 0 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Adverse Cardiac Event | Cardiac disorders | Systematic Assessment |
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Additionally, Sponsor has the right to request removal of any confidential information prior to publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Capps | CryoLife, Inc. | 800-438-8285 | brown.carolyn@cryolife.com |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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