Cardiogenesis Transmyocardial Revascularization Registry (ANGINA RELIEF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
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: June 17, 2014
Last verified: June 2014
  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 ]

Estimated Enrollment: 1000
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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

Contacts
Contact: Scott Capps, MS 770-419-3355 angina.relief@cryolife.com

Locations
United States, Arizona
University of Arizona Recruiting
Tuscon, Arizona, United States, 85722
Principal Investigator: Zain Khalpey, MD         
United States, California
California Cardiac Surgeons Recruiting
Bakersfield, California, United States, 93301
Principal Investigator: Eric Peck, MD         
The Vo Group Recruiting
Fountain Valley, California, United States, 92708
Principal Investigator: Quang Vo, MD         
Hurwitz & Roberts Med Corp Recruiting
Glendale, California, United States, 91204
Principal Investigator: Ashraf Osmand, MD         
Advanced Cardiothoracic Surgery Medical Group Recruiting
Los Angeles, California, United States, 90017
Principal Investigator: Ali Gheissari, MD         
Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group Recruiting
Northridge, California, United States, 91325
Principal Investigator: Azmi Atiya, MD         
Joseph W. Wilson, MD, Inc. Recruiting
Rancho Mirage, California, United States, 92270
Principal Investigator: Joseph W. Wilson, MD         
United States, Florida
Broward Health Medical Center Recruiting
Ft. Lauderdale, Florida, United States, 33316
Principal Investigator: Frank Catinella, MD         
Cardiothoracic and Vascular Surgical Associates Recruiting
Jacksonville, Florida, United States, 32207
Principal Investigator: Mark Mostovych, MD         
Cardiothoracic and Vascular Surgical Associates Recruiting
Jacksonville, Florida, United States, 32207
Principal Investigator: Robert Still, MD         
Coastal Cardiovascular and Thoracic Associates, PA Recruiting
Ormond Beach, Florida, United States, 32174
Principal Investigator: William H Johnson, MD         
United States, Georgia
Georgia Health Sciences University Research Institute, Inc. Recruiting
Augusta, Georgia, United States, 30912-
Principal Investigator: Vinayak Kamath, MD         
United States, Kentucky
Owensboro Health, Inc. Recruiting
Owensboro, Kentucky, United States, 42303
Principal Investigator: Sohit Khanna, MD         
Principal Investigator: Robert Adams, MD         
Regional Heart & Lung Surgery Recruiting
Paducah, Kentucky, United States, 42003
Principal Investigator: James O'Rouke, MD         
United States, Missouri
Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Principal Investigator: Keith Allen, MD         
United States, New York
The Feinstein Institute for Medical Research Recruiting
New York, New York, United States, 10075
Principal Investigator: Nirav C Patel, MD         
United States, Oklahoma
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73120
Principal Investigator: John Randolph, MD         
United States, Tennessee
East Tennessee Cardiovascular Surgery Group Recruiting
Knoxville, Tennessee, United States, 37923
Principal Investigator: Thomas Pollard, MD         
Tristar Cardiovascular Surgery Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: V. Seenu Reddy, MD         
United States, Texas
Cardiopulmonary Research Science and Technology Institute Recruiting
Dallas, Texas, United States, 75230
Principal Investigator: Tung Cai, MD         
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: June 17, 2014
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 16, 2014