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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444337
• Other study ID #: 2016H0200
• Status: Recruiting
• Start date: November 3, 2016
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: Adrianne Miller, RN
• Phone: 614-685-4394
• Email: Adrianne.Miller[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

1. LAA thrombus present on pre-procedure TEE

2. Unable to undergo MRI imaging

3. Unable to receive gadolinium contrast.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Catheter Ablation

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of FIRM targeted sites with MRI fibrotic regions	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.	Immediate post-procedure analysis
Secondary	Success or failure of electrical isolation of PV	PV analysis by intra-cardiac recordings to determine PV isolation	Immediate post-procedure
Secondary	Termination of AF or significant slowing of AF	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.	Immediate post-procedure
Secondary	Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablated	Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablated	Six months post ablation
Secondary	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.	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