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RecruitingNCT03444337Updated Sep 9, 2026

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

An observational study in Atrial Fibrillation, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • ablation
  • atrial fibrillation
  • FIRM
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  1. LAA thrombus present on pre-procedure TEE
  2. Unable to undergo MRI imaging
  3. Unable to receive gadolinium contrast.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Catheter Ablation Group

    Patients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI

    Device: Catheter Ablation

Interventions

  • DeviceCatheter Ablation
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediate post-procedure analysis

Secondary outcomes

  1. Success or failure of electrical isolation of PV

    PV analysis by intra-cardiac recordings to determine PV isolation

    Time frame: Immediate post-procedure

  2. 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.

    Time frame: Immediate post-procedure

  3. 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

    Time frame: Six months post ablation

  4. 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.

    Time frame: Six months post-ablation

06

Study locations

1 of 1 sites recruiting
  • Ohio State University
    Columbus, Ohio 43210, United States
    • Adrianne Miller, MS · Contact · Adrianne.Miller3@osumc.edu · 614-688-8252
    • Annie Kellum · Contact · Annie.Kellum@osumc.edu · 614-366-8848
    • John Hummel, MD · Principal investigator
    • Mahmoud Houmsse, MD · Sub investigator
    • Ralph Augostini, MD · Sub investigator
    • Vadim Fedorov, Phd · Sub investigator
    • Orlando Simonetti, Phd · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03444337
Lead sponsor
Ohio State University
Responsible party
John Hummel (Professor of Internal Medicine, Ohio State University) — Principal investigator
First posted
Feb 23, 2018
Start date
Nov 3, 2016
Primary completion
Dec 30, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Adrianne Miller, RN
Contact
Adrianne.Miller@osumc.edu
614-685-4394
Julie Ryan, RN
Contact
julie.ryan@osumc.edu
614-685-4394
Deanna Golden-Kreutz, RN, Phd
study director · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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