Transmyocardial Laser Revascularization and Cardiovascula... | NCT01287910

Studies
Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging

NCT01287910

Sponsor

Piedmont Healthcare

Status

Terminated

Last Update Posted

Sep 5, 2013Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Angina
Chest Pain

Interventions

Cardiac MRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of patient population

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jan 31, 2011

First Submission Date that Met QC Criteria

Feb 1, 2011

First Posted Date

Feb 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2013

Last Update Posted Date

Sep 5, 2013Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All Patients	Other	All patients undergo the same study procedures	Other: Cardiac MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac MRI	Other	Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.	All Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morris Brown, MD	Piedmont Heart Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Piedmont Heart Institute		Atlanta	Georgia	30309	United States

Condition Browse Module

MeSH Terms

ID	Term
D000787	Angina Pectoris
D002637	Chest Pain

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided