High-resolution MRI of Atrial Fibrillation Patients Prior to Focal Impulse and Rotor Modulation (FIRM) Ablation
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|ClinicalTrials.gov Identifier: NCT03444337|
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : March 23, 2023
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|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Device: Catheter Ablation|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||High-resolution Contrast-Enhanced MRI of Atrial Fibrillation Patients Prior to FIRM Ablation|
|Actual Study Start Date :||November 3, 2016|
|Estimated Primary Completion Date :||March 30, 2023|
|Estimated Study Completion Date :||September 30, 2023|
Catheter Ablation Group
Patients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI
Device: Catheter Ablation
- Correlation of FIRM targeted sites with MRI fibrotic regions [ Time Frame: 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.
- Success or failure of electrical isolation of PV [ Time Frame: Immediate post-procedure ]PV analysis by intra-cardiac recordings to determine PV isolation
- Termination of AF or significant slowing of AF [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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.
- LAA thrombus present on pre-procedure TEE
- Unable to undergo MRI imaging
- Unable to receive gadolinium contrast.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444337
|Contact: Adrianne Miller, RN||614-685-4394||Adrianne.Miller@osumc.edu|
|Contact: Julie Ryan, RNemail@example.com|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Adrianne Miller, MS 614-688-8252 Adrianne.Miller3@osumc.edu|
|Contact: Julie Ryan 614-685-4394 Julie.Ryan@osumc.edu|
|Principal Investigator: John Hummel, MD|
|Sub-Investigator: Mahmoud Houmsse, MD|
|Sub-Investigator: Ralph Augostini, MD|
|Sub-Investigator: Vadim Fedorov, Phd|
|Sub-Investigator: Orlando Simonetti, Phd|
|Study Director:||Deanna Golden-Kreutz, RN, Phd||Ohio State University|
|Responsible Party:||John Hummel, Professor of Internal Medicine, Ohio State University|
|Other Study ID Numbers:||
|First Posted:||February 23, 2018 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|