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Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging

NCT ID: NCT01287910

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Angina Chest Pain

Keywords

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Cardiac Angina Chest pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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All Patients

All patients undergo the same study procedures

Group Type OTHER

Cardiac MRI

Intervention Type OTHER

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

Interventions

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Cardiac MRI

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role collaborator

Piedmont Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morris Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Locations

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Piedmont Heart Institute

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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Amsterdam

Identifier Type: -

Identifier Source: org_study_id