N/A
N=10
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation · Longstanding Persistent Atrial Fibrillation · Atrial Fibrillation, Persistent · Arrhythmias, Cardiac
Bottom Line
View on ClinicalTrials.gov: NCT06260670 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ablacon, Inc.
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping |
10 | — |
| SECONDARY Total Number of EGF-Identified Sources |
11 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06260670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.