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High-resolution MRI of Atrial Fibrillation Patients Prior to Focal Impulse and Rotor Modulation (FIRM) Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444337
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
John Hummel, Ohio State University

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Catheter 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 : May 3, 2020
Estimated Study Completion Date : November 3, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Catheter Ablation Group
Patients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI
Device: Catheter Ablation



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Success or failure of electrical isolation of PV [ Time Frame: Immediate post-procedure ]
    PV analysis by intra-cardiac recordings to determine PV isolation

  2. 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.

  3. 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

  4. 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
Study Population
Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Adrianne Miller, RN 614-685-4394 Adrianne.Miller@osumc.edu
Contact: Julie Ryan, RN 614-685-4394 julie.ryan@osumc.edu

Locations
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United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Adrianne Miller, RN    614-685-4394    Adrianne.Miller@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         
Sub-Investigator: Jason Craft, MD         
Sponsors and Collaborators
Ohio State University
Investigators
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Study Director: Deanna Golden-Kreutz, RN, Phd Ohio State University
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Responsible Party: John Hummel, Professor of Internal Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT03444337    
Other Study ID Numbers: 2016H0200
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by John Hummel, Ohio State University:
ablation
atrial fibrillation
FIRM
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes