Arrhythmias, Cardiac, Atrial Fibrillation, Persistent, Longstanding Persistent Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Electrographic Flow Mapping
Brief summary
FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions.
Detailed 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 atrial fibrillation (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 as shown in a previously published retrospective analysis. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density (HD) mapping of those regions. FLOW EVAL-AF is a prospective, observational, single center pilot trial.
Interventions
DEVICEElectrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter
Subjects will receive ElectroGraphic Flow™ (EGF) mapping with Ablamap® Software and a commercially available 64-pole basket mapping catheter (FIRMap™ Catheter, Abbott Laboratories, Abbott park, IL). The FIRMap™ catheter will be inserted into the right and left atrium to acquire 1 minute recordings of electrical signals in several standardized positions, and turn these into electrographic flow (EGF) maps. Subjects will receive concomitant high density (HD) electroanatomical mapping of these regions with the commercially available Ensite Precision mapping system and Advisor™ HD Grid mapping catheter (Abbott Laboratories, Abbott Park, IL).
Sponsors
Ablacon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo elective catheter ablation of AF * History of persistent or longstanding persistent AF * Able to provide written informed consent prior to the procedure * Age ≥18 years
Exclusion criteria
* Presence of a permanent pacemaker or other transvenous pacing/defibrillation leads * Presence of a prosthetic mitral heart valve * Known reversible causes of AF * Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 6-month interval preceding the consent date * History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure * Unable to provide own informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping | Intraprocedural | Number of participants with successful acquisition of global electrographic flow (EGF) maps from each of the right and left atria and high density electrogram acquisitions, from at least 3 basket positions in each atrium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of EGF-Identified Sources | Intraprocedural | Total number of Active Sources, identified by Electrographic Flow™ (EGF) Mapping, in the total study population. EGF mapping uses optical flow algorithms to identify locations in the atrium that produce excitatory waves during ongoing AF, which may be detectable for varying durations of time. Sources with an active prevalence ≥ 25% were quantified as EGF-identified sources in this study. |
Countries
Germany
Participant flow
Recruitment details
Single Center in Germany
Participants by arm
| Arm | Count |
|---|---|
| EGF Mapping Group Subjects with Persistent Atrial Fibrillation who received Electrographic Flow mapping in the context of the FLOW EVAL-AF study. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | EGF Mapping Group | — |
|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 10 | — |
| CHA2DS2-VASc score | 2.5 units on a scale [scale range: 0-9] STANDARD_DEVIATION 1.2 | — |
| Left Atrium Diameter | 4.6 cm STANDARD_DEVIATION 0.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 10 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping
Number of participants with successful acquisition of global electrographic flow (EGF) maps from each of the right and left atria and high density electrogram acquisitions, from at least 3 basket positions in each atrium.
Time frame: Intraprocedural
Population: Total FLOW EVAL-AF Study Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EGF Mapping Group | Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping | 10 Participants |
Secondary
Total Number of EGF-Identified Sources
Total number of Active Sources, identified by Electrographic Flow™ (EGF) Mapping, in the total study population. EGF mapping uses optical flow algorithms to identify locations in the atrium that produce excitatory waves during ongoing AF, which may be detectable for varying durations of time. Sources with an active prevalence ≥ 25% were quantified as EGF-identified sources in this study.
Time frame: Intraprocedural
Population: Total FLOW EVAL-AF Study Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EGF Mapping Group | Total Number of EGF-Identified Sources | 11 EGF-identified Sources |