Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging (Amsterdam)

This study has been terminated.
(Lack of patient population)
Sponsor:
Collaborator:
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Information provided by (Responsible Party):
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01287910
First received: January 31, 2011
Last updated: September 4, 2013
Last verified: August 2013

January 31, 2011
September 4, 2013
January 2011
August 2013   (final data collection date for primary outcome measure)
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01287910 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging
Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Angina
  • Chest Pain
Other: Cardiac MRI
Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.
All Patients
All patients undergo the same study procedures
Intervention: Other: Cardiac MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01287910
Amsterdam
No
Piedmont Healthcare
Piedmont Healthcare
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Principal Investigator: Morris Brown, MD Piedmont Heart Institute
Piedmont Healthcare
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP