Cardiogenesis Transmyocardial Revascularization Registry (ANGINA RELIEF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| 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
|
Sponsor:
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Information provided by (Responsible Party):
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
|---|
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Angina
U.S. FDA Resources
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, Senior) |
| 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
| United States, Arizona | |
| University of Arizona | |
| Tuscon, Arizona, United States, 85722 | |
| United States, California | |
| California Cardiac Surgeons | |
| Bakersfield, California, United States, 93301 | |
| The Vo Group | |
| Fountain Valley, California, United States, 92708 | |
| Hurwitz & Roberts Med Corp | |
| Glendale, California, United States, 91204 | |
| Advanced Cardiothoracic Surgery Medical Group | |
| Los Angeles, California, United States, 90017 | |
| Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group | |
| Northridge, California, United States, 91325 | |
| Cardiovascular & Thoracic Surgeons of Ventura County, APC | |
| Oxnard, California, United States, 93030 | |
| Joseph W. Wilson, MD, Inc. | |
| Rancho Mirage, California, United States, 92270 | |
| Sutter Institute for Medical Research | |
| Sacramento, California, United States, 95819 | |
| United States, Florida | |
| Bethesda Memorial Hospital | |
| Boynton Beach, Florida, United States, 33435 | |
| Broward Health Medical Center | |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Cardiothoracic and Vascular Surgical Associates | |
| Jacksonville, Florida, United States, 32207 | |
| Coastal Cardiovascular and Thoracic Associates, PA | |
| Ormond Beach, Florida, United States, 32174 | |
| United States, Georgia | |
| Georgia Health Sciences University Research Institute, Inc. | |
| Augusta, Georgia, United States, 30912- | |
| United States, Kentucky | |
| Lexington Cardiac Research Foundation, Inc. | |
| Lexington, Kentucky, United States, 40503 | |
| Owensboro Health, Inc. | |
| Owensboro, Kentucky, United States, 42303 | |
| Regional Heart & Lung Surgery | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Missouri | |
| Saint Luke's Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| The Feinstein Institute for Medical Research | |
| New York, New York, United States, 10075 | |
| United States, Oklahoma | |
| Oklahoma Heart Hospital | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Tennessee | |
| East Tennessee Cardiovascular Surgery Group | |
| Knoxville, Tennessee, United States, 37923 | |
| Tristar Cardiovascular Surgery | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Cardiopulmonary Research Science and Technology Institute | |
| Dallas, Texas, United States, 75230 | |
Sponsors and Collaborators
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Investigators
| Study Director: | Scott Capps, MS | CryoLife, Inc. |
| Responsible Party: | Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. |
| ClinicalTrials.gov Identifier: | NCT01827319 History of Changes |
| 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.:
|
Angina Transmyocardial revascularization |
Additional relevant MeSH terms:
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Angina Pectoris Chest Pain Pain Neurologic Manifestations Nervous System Diseases |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Signs and Symptoms |