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

Ablacon, Inc.25 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation, Persistent Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases

Interventions

Electrographic Flow™ (EGF) mapping and ablationDEVICE

Electrographic Flow™ (EGF) mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF algorithm (Ablamap® Software). Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity levels exceeding the recommended threshold are deemed significant and are targeted for ablation. The success of the ablation is confirmed through an EGF remap, where elimination of the source is defined as reduction of EGF source activity below the threshold.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Piedmont Healthcare

Athens, Georgia, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Mount Sinai Hospital

New York, New York, United States

Erasmus MC

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

Number of Participants With Acute Procedure Success

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.

Time frame: During the procedure

Secondary Outcomes

Number of Participants With 12-month Freedom From AF Recurrence

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.

Time frame: 90 day - 12 months

Data from ClinicalTrials.gov

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