Cardiogenesis Transmyocardial Revascularization Registry (ANGINA RELIEF)
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| ClinicalTrials.gov Identifier: NCT01827319 |
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Recruitment Status :
Completed
First Posted : April 9, 2013
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
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Sponsor:
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Information provided by (Responsible Party):
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
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Brief Summary:
The objectives of the registry 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 and 30-day outcomes;
- Further assess the 30-day postoperative 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.
| Condition or disease |
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| Class IV Angina |
Show detailed description
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 203 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 30 Days |
| Official Title: | A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction |
| Study Start Date : | May 2013 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | June 2015 |
Primary Outcome Measures :
- All Cause Mortality [ Time Frame: 30 days ]Number of Participant Deaths
Secondary Outcome Measures :
- 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 [ Time Frame: 30 days ]
- 2 CCS Angina Class Reduction [ Time Frame: 30 days ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients who meet the eligibility criteria and undergo TMR at the selected centers will be provided an opportunity to participate.
Criteria
Inclusion Criteria:
- Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
- 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:
- Age less than18 years
- Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827319
Locations
Show 24 study locations
Sponsors and Collaborators
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Investigators
| Study Director: | Scott Capps, MS | CryoLife, Inc. |
Additional Information:
| Responsible Party: | Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. |
| ClinicalTrials.gov Identifier: | NCT01827319 |
| Other Study ID Numbers: |
TMR1201.001-M |
| First Posted: | April 9, 2013 Key Record Dates |
| Results First Posted: | August 15, 2016 |
| Last Update Posted: | August 15, 2016 |
| Last Verified: | July 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.:
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Angina Transmyocardial revascularization |
Additional relevant MeSH terms:
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Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Neurologic Manifestations |