Clinical trial NCT03444337: High-resolution MRI of Atrial Fibrillation Patients Prior to Focal Impulse and Rotor Modulation (FIRM) Ablation
Official title: High-resolution Contrast-Enhanced MRI of Atrial Fibrillation Patients Prior to FIRM Ablation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: ablation
atrial fibrillation
FIRM
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of FIRM targeted sites with MRI fibrotic regions
timeFrame: Immediate post-procedure analysis
Secondary outcomes:
measure: Success or failure of electrical isolation of PV
timeFrame: Immediate post-procedure
measure: Termination of AF or significant slowing of AF
timeFrame: Immediate post-procedure
measure: Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablated
timeFrame: Six months post ablation
measure: 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.
timeFrame: Six months post-ablation
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Deanna Golden-Kreutz, RN, Phd
role: STUDY_DIRECTOR
References: