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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation Group | Patients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate post-procedure analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Success or failure of electrical isolation of PV | PV analysis by intra-cardiac recordings to determine PV isolation | Immediate post-procedure |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrianne Miller, RN | Contact | 614-685-4394 | Adrianne.Miller@osumc.edu | |
| Julie Ryan, RN | Contact | 614-685-4394 | julie.ryan@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deanna Golden-Kreutz, RN, Phd | Ohio State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Immediate post-procedure |
| 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 | 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. | 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |