MRI Assessment of Arrythmia Ablation Lesions

Not Applicable

Completed

• Conditions: Cardiac Arrhythmia; Ventricular Tachycardia
• Interventions: Other: MRI scan

• Registration Number: NCT02761343
• Lead Sponsor: Children's National Research Institute

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Primary Completion: 2020-01-18
• Study Completion: 2020-01-18
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	Post ablation up to 5 years

Secondary Outcome Measures

Name	Time	Method
To measure the size of the ablation lesion on cardiac MR imaging	At the end of each ablation procedure through study completion, up to 5 years.
The number of post ablation MR images with a visible lesion.	At the end of each ablation procedure through study completion, up to 5 years.

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States