MRI Assessment of Arrythmia Ablation Lesions

Ventricular Tachycardia Clinical Trial

Official title:

MRI Assessment of Arrythmia Ablation Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761343
• Other study ID #: 4065
• Secondary ID: contract
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: January 18, 2020

Study information

• Verified date: January 2020
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 18, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.