Clinical trial NCT02761343: MRI Assessment of Arrythmia Ablation Lesions
Official title: MRI Assessment of Arrythmia Ablation Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Cardiac Arrhythmia
Keywords: cardiac arrhythmia
cardiac ablation
congenital cardiac disease
cardiac ablation lesions under Magnetic Resonance imaging
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-05-04
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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
timeFrame: Post ablation up to 5 years
Secondary outcomes:
measure: To measure the size of the ablation lesion on cardiac MR imaging
timeFrame: At the end of each ablation procedure through study completion, up to 5 years.
measure: The number of post ablation MR images with a visible lesion.
timeFrame: At the end of each ablation procedure through study completion, up to 5 years.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Charles Berul, MD
role: PRINCIPAL_INVESTIGATOR
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