Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF)

NCT05093868 | Withdrawn FDA Device

• 1 other identifier: 2021-021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, single center pilot trial to find out if a new computerized technology for analysis of the electrical activity recorded during atrial fibrillation can identify the electrical source of this arrhythmia. If we are able to reliably identify the source, then in the future we may be able to use this technology to determine the optimal sites for catheter ablation of atrial fibrillation in the heart. The present study will compare the standard electrical recordings to the new computerized algorithm analysis of recordings gathered at the same time. The study will enroll 30 participants with persistent or longstanding persistent atrial fibrillation (AF) that are scheduled for elective catheter ablation of AF. The catheters that are being placed in the heart are standard Food and Drug Administration (FDA)-approved mapping catheters. The investigational computerized software that will be employed in the trial will be used after the case has done and will not directly impact any of the activities during the ablation procedure. Information learned from this trial will improve understanding of the mechanisms of atrial fibrillation and will potentially improve success rates of AF ablation for patients in the future and will be used to design a prospective trial.

Conditions

Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Keywords

electrographic flow mapping; EGF; atrial fibrillation; FIRMap; Abbott Laboratories; EGF Maps; HD Grid Maps

Outcome Measures

Primary Outcomes (1)

• Number of participants with correlation in detection of sources of atrial fibrillation between the electrographic flow (EGF) mapping multielectrode basket catheter and the high-density (HD) regional mapping catheter.

  The number of participants will be reported who have the same areas identified for primary sources of AF, secondary sources of AF and passive flow regions, using the two catheter modalities.

  During elective catheter ablation procedure, an average duration of 3 to 6 hours

Secondary Outcomes (2)

• AF cycle length calculated from EGF mapping catheter

  Two-minute time intervals during elective catheter ablation procedure, an average duration of 3-6 hours

• AF cycle length calculated from HD grid regional mapping catheter

  Two-minute time intervals during elective catheter ablation procedure, an average duration of 3-6 hours

Study Arms (1)

FIRMap™ (Abbott Laboratories, Abbott Park, IL)

EXPERIMENTAL

A 64-pole basket mapping catheter (FIRMap™, Abbott Laboratories, Abbott Park, IL) will be used to passively acquire electrical signals

Device: Electrographic Flow Mapping

Interventions

Electrographic Flow Mapping DEVICE

Electrographic Flow Mapping will be collected

FIRMap™ (Abbott Laboratories, Abbott Park, IL)

Eligibility Criteria

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

You may qualify if:

• Scheduled to undergo elective catheter ablation of AF
• History of persistent or longstanding persistent AF (see definitions below)
• Able to provide written informed consent prior to the procedure
• Age ≥18 years

You may not qualify if:

• Ineligible to undergo elective atrial fibrillation ablation procedure due to medical illness or poor medical condition
• Presence of a permanent endocardial pacemaker or ICD (implantable cardioverter defibrillator)
• Presence of a prosthetic mitral heart valve
• Known reversible causes of AF including clinical hyperthyroidism, pericarditis/pleuritis or other active systemic inflammatory disease including post pericardiotomy syndrome, systemic lupus erythematosus, sarcoidosis and rheumatoid arthritis
• Decompensated clinical heart failure (NYHA class 4)
• Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 6-month interval preceding the consent date
• History of systemic thromboembolic event defined as clinical and arteriographic evidence of thromboembolism to any distal arterial vascular bed within the past 6 months, or evidence of intracardiac thrombus at the time of the procedure
• Pregnancy (pre-procedure pregnancy serum test will be performed in all premenopausal women)
• Unable to provide own informed consent due to cognitive impairment

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Nishaki Mehta, MD

  Corewell Health East

  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: October 14, 2021
• First Posted: October 26, 2021
• Study Start: September 2, 2022
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)