MRI Assessment of Arrythmia Ablation Lesions

Children's National Research Institute16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ventricular Tachycardia Cardiac Arrhythmia

Interventions

MRI scanOTHER

Following the clinically indicated cardiac ablation procedure, a post ablation MRI scan will be performed.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Children's National Health System

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

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.

Data from ClinicalTrials.gov

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