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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

LAA thrombus present on pre-procedure TEE

Unable to undergo MRI imaging

Unable to receive gadolinium contrast.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Catheter Ablation

    Device

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Catheter Ablation Group1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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