MRI Assessment of Arrythmia Ablation Lesions

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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