Trial Outcomes & Findings for AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation (NCT NCT05481359)

Last Updated: 2025-04-10

Results Overview

Acute Procedure Success is defined as targeting and successful elimination of significant sources of electrographic flow (EGF) through radiofrequency ablation. EGF-identified sources are significant when their leading source activity is ≥ 26%. Successful elimination is defined as reduction of the source activity of the leading source to \<26% upon post-ablation remapping using EGF mapping.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

During the procedure

Results posted on

2025-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Electrographic Flow™ Guided Ablation Therapy In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects received targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping.
Overall Study STARTED	25
Overall Study Subjects With at Least One EGF-identified Source Detected	16
Overall Study Received EGF-guided Ablation	13
Overall Study Did Not Receive EGF-guided Ablation	12
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Electrographic Flow™ Guided Ablation Therapy In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects received targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrographic Flow™ Guided Ablation Therapy n=25 Participants In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping.
Age, Continuous	63.9 Years STANDARD_DEVIATION 11.2 • n=25 Participants
Sex: Female, Male Female	9 Participants n=25 Participants
Sex: Female, Male Male	16 Participants n=25 Participants
Region of Enrollment Netherlands	6 participants n=25 Participants
Region of Enrollment United States	9 participants n=25 Participants
Region of Enrollment Poland	10 participants n=25 Participants
Body Mass Index, Continuous	27.9 kg/m2 STANDARD_DEVIATION 3.9 • n=25 Participants
CHA2DS2VASc score, Categorical	2.7 units on a scale [scale range: 0-9] STANDARD_DEVIATION 1.9 • n=25 Participants
Left Atrial Diameter	4.4 cm n=25 Participants
Left Atrial Volume Index	40 mL/m2 n=25 Participants
Left Ventricular Ejection Fraction, Continuous	55 % n=25 Participants
Paroxysmal AF	9 Participants n=25 Participants
Persistent Atrial Fibrillation	14 Participants n=25 Participants
Long-standing persistent AF	2 Participants n=25 Participants

PRIMARY outcome

Timeframe: During the procedure

Population: Subjects treated optimally per protocol

Outcome measures

Outcome measures
Measure	Subjects With EGF Identified Sources n=13 Participants Subjects in whom the physician elected to target Electrographic Flow™ (EGF)-identified sources \> 26% using RF ablation.	Subjects That Did Not Receive EGF-guided Ablation Subjects who did not receive Electrographic Flow™ (EGF) guided ablation, which included: * Subjects not inducible in AF after pulmonary vein isolation, preventing EGF mapping * Subjects with no EGF-identified sources above threshold on EGF mapping * Subjects where the physician elected not to ablate an EGF-identified source above threshold
Number of Participants With Acute Procedure Success	13 Participants	—

SECONDARY outcome

Timeframe: 90 day - 12 months

Population: The analysis population for the secondary outcome consisted of two groups: Group 1: Subjects who received EGF-guided ablation Group 2: Subjects who did not receive EGF-guided ablation, which included: * Subjects not inducible in AF after pulmonary vein isolation, preventing EGF mapping * Subjects with no EGF-identified sources above threshold (≥26%) on EGF mapping * Subjects where the physician elected not to ablate an EGF-identified source above threshold

This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up. Only subjects with completed 12 month follow-up are included in this analysis.

Outcome measures

Outcome measures
Measure	Subjects With EGF Identified Sources n=11 Participants Subjects in whom the physician elected to target Electrographic Flow™ (EGF)-identified sources \> 26% using RF ablation.	Subjects That Did Not Receive EGF-guided Ablation n=10 Participants Subjects who did not receive Electrographic Flow™ (EGF) guided ablation, which included: * Subjects not inducible in AF after pulmonary vein isolation, preventing EGF mapping * Subjects with no EGF-identified sources above threshold on EGF mapping * Subjects where the physician elected not to ablate an EGF-identified source above threshold
Number of Participants With 12-month Freedom From AF Recurrence	8 Participants	6 Participants

Adverse Events

Subjects That Received EGF-guided Ablation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subjects That Did Not Receive EGF-guided Ablation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subjects That Received EGF-guided Ablation n=13 participants at risk Subjects who received Electrographic Flow™ (EGF) guided ablation of one or more EGF-identified sources with an activity above threshold	Subjects That Did Not Receive EGF-guided Ablation n=12 participants at risk Subjects who did not receive Electrographic Flow™ (EGF) guided ablation, which included: * Subjects not inducible in AF after pulmonary vein isolation, preventing EGF mapping * Subjects with no EGF-identified sources above threshold on EGF mapping * Subjects where the physician elected not to ablate an EGF-identified source above threshold
Vascular disorders Hemorrhage of iliac vein with retroperitoneal hematoma	0.00% 0/13 • From Index Procedure to 12 Month Follow Up	8.3% 1/12 • Number of events 1 • From Index Procedure to 12 Month Follow Up

Other adverse events

Other adverse events
Measure	Subjects That Received EGF-guided Ablation n=13 participants at risk Subjects who received Electrographic Flow™ (EGF) guided ablation of one or more EGF-identified sources with an activity above threshold	Subjects That Did Not Receive EGF-guided Ablation n=12 participants at risk Subjects who did not receive Electrographic Flow™ (EGF) guided ablation, which included: * Subjects not inducible in AF after pulmonary vein isolation, preventing EGF mapping * Subjects with no EGF-identified sources above threshold on EGF mapping * Subjects where the physician elected not to ablate an EGF-identified source above threshold
Renal and urinary disorders Urinary Tract Infection	0.00% 0/13 • From Index Procedure to 12 Month Follow Up	8.3% 1/12 • Number of events 1 • From Index Procedure to 12 Month Follow Up

Additional Information

Eliza Lawrence

Cortex, Inc

Phone: +16507049907

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place