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

April 9, 2025 updated by: Ablacon, Inc.

A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using Electrographic Flow (EGF™) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation in Real-world Setting.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3015GD
        • Erasmus MC
  • Poland
      • Warsaw, Poland, 02-972
        • Medicover Hospital
  • United States
    • Georgia
      • Athens, Georgia, United States, 30606
        • Piedmont Healthcare
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be selected from the investigators' general patient population with a history of atrial fibrillation that meet eligibility criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Electrographic Flow™ guided ablation therapy
In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by EGF mapping.
Device: Electrographic Flow™ (EGF) mapping and ablation

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.

Other Names:
  • OptiMap™
  • Ablamap®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Acute Procedure Success
Time Frame: 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.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 12-month Freedom From AF Recurrence
Time Frame: 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.
90 day - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ablacon, Inc.

Collaborators

Cortex

Investigators

  • Principal Investigator: Kent Nilsson, MD, Piedmont Athens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

October 27, 2022

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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