Cardiogenesis Transmyocardial Revascularization Registry (ANGINA RELIEF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01827319
First received: April 5, 2013
Last updated: July 6, 2016
Last verified: July 2016

April 5, 2013
July 6, 2016
May 2013
April 2015   (final data collection date for primary outcome measure)
All Cause Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Number of Participant Deaths
All Cause Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01827319 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
  • Angina class [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cardiogenesis Transmyocardial Revascularization Registry
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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
30 Days
Not Provided
Non-Probability Sample
All patients who meet the eligibility criteria and undergo TMR at the selected centers will be provided an opportunity to participate.
Class IV Angina
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
June 2015
April 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01827319
TMR1201.001-M
No
No
Not Provided
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Not Provided
Study Director: Scott Capps, MS CryoLife, Inc.
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP