Trial Outcomes & Findings for FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation (NCT NCT06260670)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Intraprocedural

Results posted on

2025-04-10

Participant Flow

Single Center in Germany

Participant milestones

Participant milestones
Measure	EGF Mapping Group Subjects with Persistent Atrial Fibrillation who received Electrographic Flow mapping in the context of the FLOW EVAL-AF study.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EGF Mapping Group n=10 Participants Subjects with Persistent Atrial Fibrillation who received Electrographic Flow mapping in the context of the FLOW EVAL-AF study.
Age, Continuous	69 years STANDARD_DEVIATION 10 • n=10 Participants
Sex: Female, Male Female	1 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=10 Participants
Region of Enrollment Germany	10 participants n=10 Participants
Left Atrium Diameter	4.6 cm STANDARD_DEVIATION 0.5 • n=10 Participants
CHA2DS2-VASc score	2.5 units on a scale [scale range: 0-9] STANDARD_DEVIATION 1.2 • n=10 Participants

PRIMARY outcome

Timeframe: Intraprocedural

Population: Total FLOW EVAL-AF Study Population

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.

Outcome measures

Outcome measures
Measure	EGF Mapping Group n=10 Participants All subjects in the FLOW EVAL-AF study.
Number of Participants With Successful Acquisition of EGF Mapping and High Density Mapping	10 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: Total FLOW EVAL-AF Study Population

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.

Outcome measures

Outcome measures
Measure	EGF Mapping Group n=10 Participants All subjects in the FLOW EVAL-AF study.
Total Number of EGF-Identified Sources	11 EGF-identified Sources

Adverse Events

EGF Mapping Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eliza Lawrence

Ablacon, Inc

Phone: +16507049907

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place