MRI Assessment of Arrythmia Ablation Lesions

Children's National

Status: Completed

Conditions: Cardiac Arrhythmia; Ventricular Tachycardia

Treatments: Other: MRI scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02761343

4065

contract (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

MRI scan

Other group

Description:

Post ablation MRI scan will be performed for all subjects who are clinically stable.

Treatment:

Other: MRI scan