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

Recruiting
Conditions
Atrial Fibrillation
Interventions
Device: Catheter Ablation
Registration Number
NCT03444337
Lead Sponsor
Ohio State University
Brief 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
Inclusion Criteria
  1. Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI.
  2. Subjects must be at least 18 years of age.
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Exclusion Criteria
  1. LAA thrombus present on pre-procedure TEE
  2. Unable to undergo MRI imaging
  3. Unable to receive gadolinium contrast.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Catheter Ablation GroupCatheter AblationPatients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI
Primary Outcome Measures
NameTimeMethod
Correlation of FIRM targeted sites with MRI fibrotic regionsImmediate post-procedure analysis

The primary endpoint of this study will be the presence or absence of a correlation between micro-anatomic fibrotic tracks of reentry, determined by a combination of atrial wall thickness, and local scar and fibrosis, and sites of FIRM map indicated rotor activity.

Secondary Outcome Measures
NameTimeMethod
Termination of AF or significant slowing of AFImmediate post-procedure

Incidence of early termination or \>10% increase in AF cycle length at the site of FIRM detected rotor formation and whether there is a correlation with fibrotic scar.

Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablatedSix months post ablation

Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablated

Success or failure of electrical isolation of PVImmediate post-procedure

PV analysis by intra-cardiac recordings to determine PV isolation

e. Correlation of absence atrial tachycardia or atrial flutter 6 months post ablation with connection of FIRM sites to areas of fibrotic scar or anatomic barriers.Six months post-ablation

e. Correlation of absence atrial tachycardia or atrial flutter 6 months post ablation with connection of FIRM sites to areas of fibrotic scar or anatomic barriers.

Trial Locations

Locations (1)

Ohio State University

🇺🇸

Columbus, Ohio, United States

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