NCT03444337

High-resolution MRI of Atrial Fibrillation Patients Prior to Focal Impulse and Rotor Modulation (FIRM) Ablation

High-resolution Contrast-Enhanced MRI of Atrial Fibrillation Patients Prior to FIRM Ablation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Patients undergoing FIRM guided ablation of atrial fibrillation will undergo high resolution MRI imaging to determine correlation of underlying anatomic fibrotic regions with FIRM targeted sites for ablation.

Detailed description

The project will be a prospective trial involving patients consented for a clinically indicated atrial fibrillation (AF) ablation using FIRM mapping. The purpose of the study is to collect additional information before, during, and after the ablation procedure. All patients will undergo a contrast-enhance MRI scanning with gadolinium-based contrast agent prior to the procedure as it provides a 3-dimensional image of both the left atria and right atria. The primary endpoint of this study will be the presence or absence of a correlation between micro-anatomic fibrotic tracks, determined by a combination of atrial wall thickness, and local scar and fibrosis, and sites of FIRM map indicated rotor activity. Medical information will also be collected after the patients 2nd, 3rd and 6 month standard of care doctor visits. There are no additional risks associated with this protocol over and above that of the standard risk of atrial fibrillation ablation with FIRM, and those associated with the standard risk of magnetic resonance imaging with gadolinium contrast agent, but there is a small risk of the loss of confidentiality when participating in an observational study. The potential benefits includes the possibility of greater understanding of the patient's specific disease state.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Catheter Ablation

Timeline

• Start date: 2016-11-03
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2018-02-23
• Last updated: 2024-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study