Cardiogenesis Transmyocardial Revascularization Registry - Full Text View

Purpose

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
Class IV Angina


Study Type:	Observational [Patient Registry]
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Angina

U.S. FDA Resources

Further study details as provided by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.:

Primary Outcome Measures:

All Cause Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
2 CCS Angina Class Reduction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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.


Enrollment:	203
Study Start Date:	May 2013
Study Completion Date:	June 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.

More Information


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
Study First Received:	April 5, 2013
Results First Received:	May 23, 2016
Last Updated:	July 6, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.:


Angina Transmyocardial revascularization

Additional relevant MeSH terms:


Angina Pectoris Chest Pain Pain Neurologic Manifestations Nervous System Diseases	Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016

Cardiogenesis Transmyocardial Revascularization Registry (ANGINA RELIEF)