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 volunteersQualifiers
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
Case-only
Prospective
Treatments tested in this trial
Catheter Ablation
Device
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Success or failure of electrical isolation of PV
PV analysis by intra-cardiac recordings to determine PV isolation
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.
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
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.
Sponsors and contacts
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