Utilizing a Novel Method to Map Sources of Atrial Fibrillation

NCT02523534 | Completed

• 2 other identifiers: STU002008091R01HL125881-01A1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an electrogram mapping study that tests the ability of a new signal processing technique called electrogram morphology recurrence mapping to locate drivers in participants with atrial fibrillation. This study will also test the hypothesis that there are non-invasive markers that can predict driver location. Electrogram mapping will be performed in participants undergoing ablation for persistent atrial fibrillation. These participants will have a cardiac MRI and 12-lead ECG prior to the ablation procedure.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Utilize MRI and ECG to map electrogram morphology recurrence in participants with Atrial Fibrillation undergoing an ablation procedure.

  The MRI data captured will be used to calculate geometric wall stress and quantify fibrosis. The ECG will allow for a frequency domain analysis to estimate atrial rate and organization of atrial activity during atrial fibrillation. Together MRI and ECG data will provide a detailed map of electrogram morphology.

  4 hours

Study Arms (1)

Recurrence Mapping

EXPERIMENTAL

Participant undergoing their first ablation that fit our inclusion/exclusion criteria will undergo new atrial fibrillation mapping techniques to help identify the sources of atrial fibrillation. The participant will have an MRI and ECG prior to a clinically indicated ablation.

Procedure: MRI; Procedure: ECG

Interventions

MRI PROCEDURE

MRI images will be taken in conjunction with the clinically indicated cardiac MRI.

Also known as: Magnetic Resonance Imagining

Recurrence Mapping

ECG PROCEDURE

ECG readings will be taken prior to the participants clinically indicated procedure.

Also known as: Electrocardiogram

Recurrence Mapping

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, At least 21 years of age.
• Subjects with persistent AF undergoing a first catheter ablation procedure.

You may not qualify if:

• Inability to sign consent.
• Patients with a life expectancy \<1 year.
• Previous ablation of the atria
• Pregnant women and women that are breast feeding.
• Subjects with contraindication to MRI such as cochlear implants, ocular foreign body (e.g. metal shavings), brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator.

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Ng, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: November 7, 2023

Record last verified: 2023-11