Cardiogenesis Transmyocardial Revascularization Registry
ANGINA RELIEF
A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction
1 other identifier
observational
203
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
August 15, 2016
CompletedAugust 15, 2016
July 1, 2016
1.9 years
April 5, 2013
May 23, 2016
July 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All Cause Mortality
Number of Participant Deaths
30 days
Secondary Outcomes (2)
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
30 days
2 CCS Angina Class Reduction
30 days
Eligibility Criteria
All patients who meet the eligibility criteria and undergo TMR at the selected centers will be provided an opportunity to participate.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Arizona
Tuscon, Arizona, 85722, United States
California Cardiac Surgeons
Bakersfield, California, 93301, United States
The Vo Group
Fountain Valley, California, 92708, United States
Hurwitz & Roberts Med Corp
Glendale, California, 91204, United States
Advanced Cardiothoracic Surgery Medical Group
Los Angeles, California, 90017, United States
Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group
Northridge, California, 91325, United States
Cardiovascular & Thoracic Surgeons of Ventura County, APC
Oxnard, California, 93030, United States
Joseph W. Wilson, MD, Inc.
Rancho Mirage, California, 92270, United States
Sutter Institute for Medical Research
Sacramento, California, 95819, United States
Bethesda Memorial Hospital
Boynton Beach, Florida, 33435, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Cardiothoracic and Vascular Surgical Associates
Jacksonville, Florida, 32207, United States
Coastal Cardiovascular and Thoracic Associates, PA
Ormond Beach, Florida, 32174, United States
Georgia Health Sciences University Research Institute, Inc.
Augusta, Georgia, 30912-, United States
Lexington Cardiac Research Foundation, Inc.
Lexington, Kentucky, 40503, United States
Owensboro Health, Inc.
Owensboro, Kentucky, 42303, United States
Regional Heart & Lung Surgery
Paducah, Kentucky, 42003, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Feinstein Institute for Medical Research
New York, New York, 10075, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
East Tennessee Cardiovascular Surgery Group
Knoxville, Tennessee, 37923, United States
Tristar Cardiovascular Surgery
Nashville, Tennessee, 37203, United States
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Capps
- Organization
- CryoLife, Inc.
Study Officials
- STUDY DIRECTOR
Scott Capps, MS
CryoLife, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2013
First Posted
April 9, 2013
Study Start
May 1, 2013
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
August 15, 2016
Results First Posted
August 15, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share