Class IV AnginaANGINA RELIEFNCT01827319
Cardiogenesis Transmyocardial Revascularization Registry
An observational study of Class IV Angina, run by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. at 24 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Class IV Angina
- How many people
- 203 participants
- Where
- 24 sitesUnited States
- Study dates
- May 2013to Jun 2015
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the eligibility criteria and undergo TMR at the selected centers will be provided an opportunity to participate.
Who may be able to join
- 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)
Who cannot join
- Age less than18 years
- Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Georgia Health Sciences University Research Institute, Inc.
Augusta, Georgia, 30912-
California Cardiac Surgeons
Bakersfield, California, 93301
Bethesda Memorial Hospital
Boynton Beach, Florida, 33435
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
The Vo Group
Fountain Valley, California, 92708
Hurwitz & Roberts Med Corp
Glendale, California, 91204
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cardiothoracic and Vascular Surgical Associates
Jacksonville, Florida, 32207
Saint Luke's Hospital
Kansas City, Missouri, 64111
East Tennessee Cardiovascular Surgery Group
Knoxville, Tennessee, 37923
Lexington Cardiac Research Foundation, Inc.
Lexington, Kentucky, 40503
Advanced Cardiothoracic Surgery Medical Group
Los Angeles, California, 90017
Tristar Cardiovascular Surgery
Nashville, Tennessee, 37203
The Feinstein Institute for Medical Research
New York, New York, 10075
Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group
Northridge, California, 91325
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Coastal Cardiovascular and Thoracic Associates, PA
Ormond Beach, Florida, 32174
Owensboro Health, Inc.
Owensboro, Kentucky, 42303
Cardiovascular & Thoracic Surgeons of Ventura County, APC
Oxnard, California, 93030
Regional Heart & Lung Surgery
Paducah, Kentucky, 42003
Joseph W. Wilson, MD, Inc.
Rancho Mirage, California, 92270
Sutter Institute for Medical Research
Sacramento, California, 95819
University of Arizona
Tuscon, Arizona, 85722
About this study
Official title: A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction
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.
Read the 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
- Keywords
- Angina, Transmyocardial revascularization
- Medical subject headings
- Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Number of Participant Deaths
Measured: 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
Measured: 30 days
2 CCS Angina Class Reduction
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Class IV AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Capps, MS, Study director, CryoLife, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827319
- Sponsor's protocol ID
- TMR1201.001-M
- Acronym
- ANGINA RELIEF
- Status last verified
- Jul 2016
- First submitted
- 5 Apr 2013
- Last updated
- 15 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction
- ClinicalTrials.gov ID
- NCT01827319
- Acronym / sponsor ID
- ANGINA RELIEF / TMR1201.001-M
- Conditions
- Class IV Angina
- Keywords
- Angina, Transmyocardial revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the eligibility criteria and undergo TMR at the selected centers will be provided an opportunity to participate.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Age less than18 years
- Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All Cause Mortality
Time frame: 30 days
Number of Participant Deaths
2 secondary outcomes
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
2 CCS Angina Class Reduction
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Capps, MS study director
CryoLife, Inc.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Class IV Angina, run by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cause Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.