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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Catheter 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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Adrianne Miller, RN; Phone Number: 614-685-4394; Email: Adrianne.Miller@osumc.edu
• Study Contact Backup: Name: Julie Ryan, RN; Phone Number: 614-685-4394; Email: julie.ryan@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Principal Investigator: John Hummel, MD
      • Sub-Investigator: Mahmoud Houmsse, MD
      • Contact: Adrianne Miller, MS; Phone Number: 614-688-8252; Email: Adrianne.Miller3@osumc.edu
      • Contact: Julie Ryan; Phone Number: 614-685-4394; Email: Julie.Ryan@osumc.edu
      • Sub-Investigator: Ralph Augostini, MD
      • Sub-Investigator: Vadim Fedorov, Phd
      • Sub-Investigator: Orlando Simonetti, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Catheter Ablation Group; Patients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI	Device: Catheter Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success or failure of electrical isolation of PV	PV analysis by intra-cardiac recordings to determine PV isolation	Immediate post-procedure
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
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
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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Study Director: Deanna Golden-Kreutz, RN, Phd, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: February 18, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation; FIRM
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2016H0200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes