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Completed

NCT Number: NCT02761343

MRI Assessment of Arrythmia Ablation Lesions

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Arrhythmia Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI scan

Other

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 4, 2016
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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