Atrial Fibrillation
Conditions
Keywords
ablation, atrial fibrillation, FIRM
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.
Interventions
DEVICECatheter Ablation
Sponsors
Ohio State University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of FIRM targeted sites with MRI fibrotic regions | 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
| Measure | Time frame | Description |
|---|---|---|
| Success or failure of electrical isolation of PV | Immediate post-procedure | PV analysis by intra-cardiac recordings to determine PV isolation |
| Termination of AF or significant slowing of AF | 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. |
| Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablated | Six months post ablation | 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. | 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. |
Countries
United States
Contacts
CONTACTAdrianne Miller, RN
CONTACTJulie Ryan, RN
STUDY_DIRECTORDeanna Golden-Kreutz, RN, Phd
Ohio State University
Outcome results
None listed