Cardiogenesis Transmyocardial Revascularization Registry

NCT ID: NCT01827319

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-06-30

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.

Detailed Description

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.

Conditions

Class IV Angina

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Capps, MS

Role: STUDY_DIRECTOR

CryoLife, Inc.

Locations

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

Countries

United States

Other Identifiers

TMR1201.001-M

Identifier Type: -

Identifier Source: org_study_id