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

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.

Study Overview

• Status: Completed
• Conditions: Class IV Angina

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 Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tuscon, Arizona, United States, 85722
      • University of Arizona
  • California
    • Bakersfield, California, United States, 93301
      • California Cardiac Surgeons
    • Fountain Valley, California, United States, 92708
      • The Vo Group
    • Glendale, California, United States, 91204
      • Hurwitz & Roberts Med Corp
    • Los Angeles, California, United States, 90017
      • Advanced Cardiothoracic Surgery Medical Group
    • Northridge, California, United States, 91325
      • Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group
    • Oxnard, California, United States, 93030
      • Cardiovascular & Thoracic Surgeons of Ventura County, APC
    • Rancho Mirage, California, United States, 92270
      • Joseph W. Wilson, MD, Inc.
    • Sacramento, California, United States, 95819
      • Sutter Institute for Medical Research
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Bethesda Memorial Hospital
    • Ft. Lauderdale, Florida, United States, 33316
      • Broward Health Medical Center
    • Jacksonville, Florida, United States, 32207
      • Cardiothoracic and Vascular Surgical Associates
    • Ormond Beach, Florida, United States, 32174
      • Coastal Cardiovascular and Thoracic Associates, PA
  • Georgia
    • Augusta, Georgia, United States, 30912-
      • Georgia Health Sciences University Research Institute, Inc.
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Lexington Cardiac Research Foundation, Inc.
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Health, Inc.
    • Paducah, Kentucky, United States, 42003
      • Regional Heart & Lung Surgery
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10075
      • The Feinstein Institute for Medical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • East Tennessee Cardiovascular Surgery Group
    • Nashville, Tennessee, United States, 37203
      • TriStar Cardiovascular Surgery
  • Texas
    • Dallas, Texas, United States, 75230
      • Cardiopulmonary Research Science and Technology Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cause Mortality	Number of Participant Deaths	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	30 days

Collaborators and Investigators

• Sponsor: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
• Investigators: Study Director: Scott Capps, MS, CryoLife, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Angina; Transmyocardial revascularization
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: TMR1201.001-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO