Cardiogenesis Transmyocardial Revascularization Registry

Completed

Conditions studied: Class IV Angina

In brief

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.

Key facts

Study ID

NCT01827319

Run by

Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.

People needed

203

Starts

2013-05-01

Expected to finish

2015-06-01

Last updated by the study team

2016-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Age less than18 years
• Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)

Where it is running

• University of Arizona — Tuscon, Arizona, United States
• California Cardiac Surgeons — Bakersfield, California, United States
• The Vo Group — Fountain Valley, California, United States
• Hurwitz & Roberts Med Corp — Glendale, California, United States
• Advanced Cardiothoracic Surgery Medical Group — Los Angeles, California, United States
• Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group — Northridge, California, United States
• Cardiovascular & Thoracic Surgeons of Ventura County, APC — Oxnard, California, United States
• Joseph W. Wilson, MD, Inc. — Rancho Mirage, California, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• Bethesda Memorial Hospital — Boynton Beach, Florida, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Cardiothoracic and Vascular Surgical Associates — Jacksonville, Florida, United States
• Coastal Cardiovascular and Thoracic Associates, PA — Ormond Beach, Florida, United States
• Georgia Health Sciences University Research Institute, Inc. — Augusta, Georgia, United States
• Lexington Cardiac Research Foundation, Inc. — Lexington, Kentucky, United States
• Owensboro Health, Inc. — Owensboro, Kentucky, United States
• Regional Heart & Lung Surgery — Paducah, Kentucky, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Feinstein Institute for Medical Research — New York, New York, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• East Tennessee Cardiovascular Surgery Group — Knoxville, Tennessee, United States
• Tristar Cardiovascular Surgery — Nashville, Tennessee, United States
• Cardiopulmonary Research Science and Technology Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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