Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging (Amsterdam)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01287910
Recruitment Status : Terminated (Lack of patient population)
First Posted : February 2, 2011
Last Update Posted : September 5, 2013
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Information provided by (Responsible Party):
Piedmont Healthcare

Brief Summary:
The primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients.

Condition or disease Intervention/treatment Phase
Angina Chest Pain Other: Cardiac MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography
Study Start Date : January 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
All Patients
All patients undergo the same study procedures
Other: Cardiac MRI
Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.

Primary Outcome Measures :
  1. Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female 18 years of age or over
  • Patients with medically refractory, severe, class III or IV angina based on the Canadian Cardiovascular Society angina scale as determined by a physician
  • Ejection fraction 25% or greater
  • Patients with significant ischemia in the myocardium and who are NOT candidates for treatment by direct coronary revascularization methods (i.e., CABG or PCI)
  • Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria:

  • Patient cannot undergo a surgical procedure or general anesthesia
  • Patient not eligible for CMR study
  • Severe unstable angina
  • Q-wave MI within 3 weeks prior to TMR
  • NQWMI within 2 weeks prior to TMR
  • Decompensated heart failure (class III/IV) at the time of procedure
  • Known increased bleeding risk
  • Implanted pacemaker or defibrillator
  • Clinically unstable arrhythmia
  • Not able or willing to adhere to the study tests and procedures
  • Inability or unwillingness to consent and Authorization for use of PHI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01287910

United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Principal Investigator: Morris Brown, MD Piedmont Heart Institute

Responsible Party: Piedmont Healthcare Identifier: NCT01287910     History of Changes
Other Study ID Numbers: Amsterdam
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: August 2013

Keywords provided by Piedmont Healthcare:
Chest pain

Additional relevant MeSH terms:
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms