Cardiogenesis Transmyocardial Revascularization Registry

Class IV Angina Clinical Trial

— ANGINA RELIEF  

Official title:

A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827319
• Other study ID #: TMR1201.001-M
• Status: Completed
• Phase: N/A
• First received: April 5, 2013
• Last updated: July 27, 2015
• Start date: May 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical 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;

• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Class IV Angina

Locations

Country	Name	City	State
United States	Georgia Health Sciences University Research Institute, Inc.	Augusta	Georgia
United States	California Cardiac Surgeons	Bakersfield	California
United States	Bethesda Memorial Hospital	Boynton Beach	Florida
United States	Cardiopulmonary Research Science and Technology Institute	Dallas	Texas
United States	The Vo Group	Fountain Valley	California
United States	Broward Health Medical Center	Ft. Lauderdale	Florida
United States	Hurwitz & Roberts Med Corp	Glendale	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Cardiothoracic and Vascular Surgical Associates	Jacksonville	Florida
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	East Tennessee Cardiovascular Surgery Group	Knoxville	Tennessee
United States	Lexington Cardiac Research Foundation, Inc.	Lexington	Kentucky
United States	Advanced Cardiothoracic Surgery Medical Group	Los Angeles	California
United States	Tristar Cardiovascular Surgery	Nashville	Tennessee
United States	The Feinstein Institute for Medical Research	New York	New York
United States	Soltero & Yasuda Associates Cardiothoracic & Vascular Medical Group	Northridge	California
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Coastal Cardiovascular and Thoracic Associates, PA	Ormond Beach	Florida
United States	Owensboro Health, Inc.	Owensboro	Kentucky
United States	Cardiovascular & Thoracic Surgeons of Ventura County, APC	Oxnard	California
United States	Regional Heart & Lung Surgery	Paducah	Kentucky
United States	Joseph W. Wilson, MD, Inc.	Rancho Mirage	California
United States	Sutter Institute for Medical Research	Sacramento	California
United States	University of Arizona	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		30 days	No
Secondary	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	No
Secondary	Angina class		30 days	No