AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases
• Interventions: Device: Ablamap Software

• Registration Number: NCT05481359
• Lead Sponsor: Ablacon, Inc.

Brief Summary

This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.

Detailed Description

The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2022-09-12
• Primary Completion: 2022-10-27
• Study Completion: 2023-11-17
• Results First Submitted: 2025-02-14
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Results First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.
2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
3. Subjects with a history of documented symptomatic atrial fibrillation.

Exclusion Criteria

1. Subjects who are not candidates for cardiac ablation procedures.
2. Pregnant or nursing.
3. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EGF-Guided Ablation Therapy	Ablamap Software	Subjects will be treated with cardiac ablation guided by the Ablamap Electrographic Flow (EGF) Mapping System.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Procedure Success	During the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With 12-month Freedom From AF Recurrence	90 day - 12 months	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.

Trial Locations

Locations (5)

Piedmont Atlanta Hospital; 🇺🇸 Atlanta, Georgia, United States

Erasmus MC; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

Medicover Hospital; 🇵🇱 Warsaw, Poland

Piedmont Healthcare; 🇺🇸 Athens, Georgia, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States