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NCT01827319 · ClinicalTrials.gov registry record
Cardiogenesis Transmyocardial Revascularization Registry
A clinical trial of Class IV Angina, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.
- Completed
- Registry status
- 203
- Enrollment target
- 20
- Study locations
NCT01827319: Completed study of Class IV Angina, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.
NCT01827319 is a study of Class IV Angina that has completed, run by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife. The registered enrollment target is 203 participants. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827319, a study of Class IV Angina, has completed, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.
- COMPLETED
- Registry status
- 203 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Number of Participant Deaths
Conditions Studied
Study Locations (20)
California
- California Cardiac Surgeons - Bakersfield
- The Vo Group - Fountain Valley
- Hurwitz & Roberts Med Corp - Glendale
- Advanced Cardiothoracic Surgery Medical Group - Los Angeles
- Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group - Northridge
- Cardiovascular & Thoracic Surgeons of Ventura County, APC - Oxnard
- Joseph W. Wilson, MD, Inc. - Rancho Mirage
- Sutter Institute for Medical Research - Sacramento
Florida
- Bethesda Memorial Hospital - Boynton Beach
- Broward Health Medical Center - Fort Lauderdale
- Cardiothoracic and Vascular Surgical Associates - Jacksonville
- Coastal Cardiovascular and Thoracic Associates, PA - Ormond Beach
Kentucky
- Lexington Cardiac Research Foundation, Inc. - Lexington
- Owensboro Health, Inc. - Owensboro
- Regional Heart & Lung Surgery - Paducah
Arizona
- University of Arizona - Tuscon
Georgia
- Georgia Health Sciences University Research Institute, Inc. - Augusta
Missouri
- Saint Luke's Hospital - Kansas City
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- The Feinstein Institute for Medical Research - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-06 |
What the finished NCT01827319 record still lists
NCT01827319 is an observational study that tracks outcomes without assigning an intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Class IV Angina appearing as the primary indexed condition, and to 0 interventions.
NCT01827319 names 20 study sites across 8 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01827319 about?
NCT01827319 is a clinical study titled "Cardiogenesis Transmyocardial Revascularization Registry". 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 characteristi...
What is the current status of trial NCT01827319?
This trial is currently completed. The enrollment target is 203 participants. The study started on 2013-05. Estimated completion is 2015-06.
What conditions does trial NCT01827319 study?
This clinical trial studies the following conditions: Class IV Angina.
Who is sponsoring clinical trial NCT01827319?
This trial is sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01827319 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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