MRI Assessment of Arrythmia Ablation Lesions

NCT ID: NCT02761343

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-01-18

Brief Summary

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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

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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.

Conditions

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Ventricular Tachycardia Cardiac Arrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI scan

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

Group Type OTHER

MRI scan

Intervention Type OTHER

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

Interventions

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MRI scan

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Charles Berul

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Berul, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

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Children's National Health System

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

Site Status

Countries

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United States

References

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Other Identifiers

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contract

Identifier Type: OTHER

Identifier Source: secondary_id

4065

Identifier Type: -

Identifier Source: org_study_id

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