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 27, 2015
Last verified: July 2015
  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:


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 ]

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 ]
  • Angina class [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: May 2013
Study Completion Date: June 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

No publications provided

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
Last Updated: July 27, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 03, 2015