Back to resultsMRI Assessment of Arrythmia Ablation Lesions
Primary Purpose
Ventricular Tachycardia, Cardiac Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventricular Tachycardia focused on measuring cardiac arrhythmia, cardiac ablation, congenital cardiac disease, cardiac ablation lesions under Magnetic Resonance imaging
Eligibility Criteria
Inclusion Criteria:
- Written informed consent from any patient willing to participate who is undergoing an electrophysiology study with potential for arrhythmia ablation
- Written informed assent, if applicable
Exclusion Criteria:
- Women who are pregnant
- Women who are nursing and who do not plan to discard breast milk for 24 hours
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Implanted Insulin pump
- Metal shrapnel or bullet.
- Any intracardiac or intravascular device that is not MR safe or MR conditional according to the manufacturer based on both material and timing of device placement
Sites / Locations
- Children's National Health System
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI scan
Arm Description
Post ablation MRI scan will be performed for all subjects who are clinically stable.
Outcomes
Primary Outcome Measures
The number of participants following ablation procedure who: a). have an arrythmia reoccurrence, b). require a repeat ablation procedure, and c). require treatment for arrhythmia management
Secondary Outcome Measures
To measure the size of the ablation lesion on cardiac MR imaging
The number of post ablation MR images with a visible lesion.
Full Information
NCT ID
NCT02761343
First Posted
April 25, 2016
Last Updated
January 17, 2020
Sponsor
Children's National Research Institute
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02761343
Brief Title
MRI Assessment of Arrythmia Ablation Lesions
Official Title
MRI Assessment of Arrythmia Ablation Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
January 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the feasibility of visualization and characterization of arrhythmia ablation lesions by MRI immediately following standard ablation techniques. The appearance of the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia recurrence.
Detailed Description
Children's National Heart Institute (CNHI) with major contractual support from the National Institutes of Health / National Heart, Lung and Blood Institute has installed a combined X-ray / Magnetic Resonance Imaging cardiac catheterization lab suite allowing for experts in the fields of cardiac MRI, interventional cardiac MRI and clinical pediatric interventional electrophysiology to work together to make substantial advancements in the development of novel techniques and applications to reach the goal of improved survival and care for the congenital heart disease population. The CNHI X-ray/MRI suite will allow for streamlined transfer of patients from fluoroscopy directly to the MRI scanner under the same sedation thereby allowing for immediate post procedure imaging and minimizing risk to the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Cardiac Arrhythmia
Keywords
cardiac arrhythmia, cardiac ablation, congenital cardiac disease, cardiac ablation lesions under Magnetic Resonance imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI scan
Arm Type
Other
Arm Description
Post ablation MRI scan will be performed for all subjects who are clinically stable.
Intervention Type
Other
Intervention Name(s)
MRI scan
Intervention Description
Following the clinically indicated cardiac ablation procedure, a post ablation MRI scan will be performed.
Primary Outcome Measure Information:
Title
The number of participants following ablation procedure who: a). have an arrythmia reoccurrence, b). require a repeat ablation procedure, and c). require treatment for arrhythmia management
Time Frame
Post ablation up to 5 years
Secondary Outcome Measure Information:
Title
To measure the size of the ablation lesion on cardiac MR imaging
Time Frame
At the end of each ablation procedure through study completion, up to 5 years.
Title
The number of post ablation MR images with a visible lesion.
Time Frame
At the end of each ablation procedure through study completion, up to 5 years.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent from any patient willing to participate who is undergoing an electrophysiology study with potential for arrhythmia ablation
Written informed assent, if applicable
Exclusion Criteria:
Women who are pregnant
Women who are nursing and who do not plan to discard breast milk for 24 hours
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
Central nervous system aneurysm clips
Implanted neural stimulator
Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
Cochlear implant
Ocular foreign body (e.g. metal shavings)
Implanted Insulin pump
Metal shrapnel or bullet.
Any intracardiac or intravascular device that is not MR safe or MR conditional according to the manufacturer based on both material and timing of device placement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Berul, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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MRI Assessment of Arrythmia Ablation Lesions
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