Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05093868 |
| Other study ID # |
2021-021 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2, 2022 |
| Est. completion date |
September 2, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
William Beaumont Hospitals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
It is hypothesized that initiation and propagation of atrial fibrillation (AF) is dependent,
at least in part, on rapid atrial stimulation from focal sources. It is debated whether the
mechanism of arrhythmogenesis at these foci is abnormal automaticity, triggered activity,
microreentry or rotational reentry. However, after activation emerges from these "driver"
sites, fibrillatory conduction ensues resulting in the disorganized conduction pattern of AF.
Conventional mapping systems can either achieve high spatial resolution by sequential
tachycardia beats following a fixed intra-atrial activation pattern (as in macro reentrant
atrial flutter), or high temporal resolution with very low spatial resolution achieved
through multielectrode basket catheters. Activation mapping in AF with commercially available
mapping systems has been unsuccessful in identifying driver sites because atrial activation
patterns change on a beat-to-beat basis precluding the use of sequential mapping approaches,
and real-time mapping with basket electrodes lacks sufficient resolution to delineate the
complex patterns of conduction. Electrographic Flow (EGF) mapping (AblaMap®, Ablacon, Inc,
Wheat Ridge, CO) is a unique method to assess dominant patterns of intra-atrial conduction
during ongoing atrial fibrillation and has been previously described. Recordings from a
multielectrode basket catheter are analyzed for electrical activation vectors over sequential
2-second segments during a 60 second acquisition period. Patterns of reproducible vector
activation are used to identify driver sources for the AF. Multiple sources are often
identified in patients with persistent AF. It is anticipated that substrate modification of
these source regions will eliminate the AF drivers and result in a favorable response to
catheter ablation.
Participants undergoing elective catheter ablation of AF will be enrolled. During the
elective catheter ablation and during ongoing AF, A 64-pole basket mapping catheter (FIRMap™,
Abbott Laboratories, Abbott Park, IL) will be inserted into the right atrium, and electrical
signals will be passively acquired. This is the only aspect of the procedure that will be
research beyond standard of care. A 16-pole HD grid mapping catheter (Advisor™ HD Grid,
Abbott Laboratories, Abbott Park, IL) will be inserted into the right atrium and high density
electrogram signals will be recorded from each site for 2 minutes. At least 6 sites will be
assessed. After transseptal catheterization, mapping of the left atrium will proceed in a
similar fashion. Electrogram signals will be recorded in the electroanatomical mapping system
as well as the 128-channel electrophysiology recording system. The collected electrogram data
will be analyzed post procedure.
