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NCT Number: NCT03444337

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Adrianne Miller, MS

CONTACT

[email protected]

614-688-8252

Annie Kellum

CONTACT

[email protected]

614-366-8848

John Hummel, MD

PRINCIPAL_INVESTIGATOR

Mahmoud Houmsse, MD

SUB_INVESTIGATOR

Orlando Simonetti, Phd

SUB_INVESTIGATOR

Ralph Augostini, MD

SUB_INVESTIGATOR

Vadim Fedorov, Phd

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI.
  • Subjects must be at least 18 years of age.

Exclusion criteria

  • LAA thrombus present on pre-procedure TEE
  • Unable to undergo MRI imaging
  • Unable to receive gadolinium contrast.

Treatment and study plan

Catheter ablation

Device

Primary outcomes

  1. Correlation of FIRM targeted sites with MRI fibrotic regions

    Time frame: Immediate 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 outcomes

  1. Success or failure of electrical isolation of PV

    Time frame: Immediate post-procedure

    PV analysis by intra-cardiac recordings to determine PV isolation

  2. Termination of AF or significant slowing of AF

    Time frame: Immediate 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.

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

    Time frame: Six months post ablation

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

  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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrianne Miller, RN

CONTACT

[email protected]

614-685-4394

Julie Ryan, RN

CONTACT

[email protected]

614-685-4394

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2018
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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