Skip to content

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01287910
Acronym
Amsterdam
Enrollment
2
Registered
2011-02-02
Start date
2011-01-31
Completion date
2013-08-31
Last updated
2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina, Chest Pain

Keywords

Cardiac, Angina, Chest pain

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.

Interventions

OTHERCardiac MRI

Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.

Sponsors

Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
CollaboratorINDUSTRY
Piedmont Healthcare
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026