Clinical trial NCT01827319: Cardiogenesis Transmyocardial Revascularization Registry
Official title: A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Class IV Angina
Keywords: Angina
Transmyocardial revascularization
Lead sponsor: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: All Cause Mortality
timeFrame: 30 days
Secondary outcomes:
measure: 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
timeFrame: 30 days
measure: 2 CCS Angina Class Reduction
timeFrame: 30 days
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: University of Arizona
state: Arizona
city: Bakersfield
country: United States
facility: California Cardiac Surgeons
state: California
city: Fountain Valley
country: United States
facility: The Vo Group
state: California
city: Glendale
country: United States
facility: Hurwitz & Roberts Med Corp
state: California
city: Los Angeles
country: United States
facility: Advanced Cardiothoracic Surgery Medical Group
state: California
city: Northridge
country: United States
facility: Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group
state: California
city: Oxnard
country: United States
facility: Cardiovascular & Thoracic Surgeons of Ventura County, APC
state: California
city: Rancho Mirage
country: United States
facility: Joseph W. Wilson, MD, Inc.
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Boynton Beach
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Ft. Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Cardiothoracic and Vascular Surgical Associates
state: Florida
city: Ormond Beach
country: United States
facility: Coastal Cardiovascular and Thoracic Associates, PA
state: Florida
city: Augusta
country: United States
facility: Georgia Health Sciences University Research Institute, Inc.
state: Georgia
city: Lexington
country: United States
facility: Lexington Cardiac Research Foundation, Inc.
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Health, Inc.
state: Kentucky
city: Paducah
country: United States
facility: Regional Heart & Lung Surgery
state: Kentucky
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Knoxville
country: United States
facility: East Tennessee Cardiovascular Surgery Group
state: Tennessee
city: Nashville
country: United States
facility: Tristar Cardiovascular Surgery
state: Tennessee
city: Dallas
country: United States
facility: Cardiopulmonary Research Science and Technology Institute
state: Texas
Study officials:
affiliation: CryoLife, Inc.
name: Scott Capps, MS
role: STUDY_DIRECTOR
References: