MRI Assessment of Arrythmia Ablation Lesions

NCT02761343 | Completed

• 2 other identifiers: 4065contract
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; Cardiac Arrhythmia

Keywords

cardiac arrhythmia; cardiac ablation; congenital cardiac disease; cardiac ablation lesions under Magnetic Resonance imaging

Outcome Measures

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

  Post ablation up to 5 years

Secondary Outcomes (2)

• 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.

Study Arms (1)

MRI scan

OTHER

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

Other: MRI scan

Interventions

MRI scan OTHER

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

MRI scan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's National Health System

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

Location

Related Publications (40)

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MeSH Terms

Conditions

Tachycardia, Ventricular; Arrhythmias, Cardiac

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Charles Berul, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2014
• Primary Completion: January 18, 2020
• Study Completion: January 18, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)