MRI Assessment of Arrythmia Ablation Lesions

January 17, 2020 updated by: Charles Berul, Children's National Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRI scan
Post ablation MRI scan will be performed for all subjects who are clinically stable.
Other: MRI scan
Following the clinically indicated cardiac ablation procedure, a post ablation MRI scan will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Post ablation up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
At the end of each ablation procedure through study completion, up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Charles Berul, MD, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

January 18, 2020

Study Completion (Actual)

January 18, 2020

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4065
  • contract (Other Identifier: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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