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Completed

NCT Number: NCT04473963

FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology

This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).

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Key information

Conditions

Atrial Fibrillation, Persistent Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemocnice Na Homolce Hospital, Prague, Czech Republic, Czechia

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About this study

The objective of this study is to evaluate the reliability of Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software) to identify sources of atrial fibrillation and guide ablation therapy in patients with persistent atrial fibrillation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.
  • Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
  • Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation < 36 months.
  • Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
  • Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to De Novo subjects)

Exclusion criteria

  • Left atrial diameter > 5.5 cm.
  • Left ventricular ejection fraction (LVEF) < 35%.
  • Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
  • Coagulopathy, bleeding diathesis or suspected procoagulant state.
  • Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
  • Positive pregnancy test results for female patients of childbearing potential or breast feeding.
  • Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.
  • Mitral valve stenosis and/or severe mitral regurgitation.
  • Valvular atrial fibrillation.
  • Prosthetic valves.
  • New York Heart Association (NYHA) Class IV.
  • History of myocardial infarction (MI) within 3 months prior to procedure.
  • Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
  • Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
  • Life expectancy < 12 months based on medical history or the medical judgement of the investigator.
  • Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.

Treatment and study plan

Electrographic Flow™ guided ablation

Device

In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. 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 software. Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity above the threshold (≥ 26.5%) are considered significant and targeted for ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.

Other names: Electrographic Flow™ Mapping Technology, OptiMap™, Ablamap®

Primary outcomes

  1. Number of Participants With Acute Procedure Success

    Time frame: During the Procedure

    Acute Procedure Success is defined as successful elimination of significant sources of electrographic flow (EGF) through targeted radiofrequency ablation. EGF-identified sources are significant when their leading source activity is above threshold. Successful elimination is defined as reduction of the source activity of the leading source below threshold upon post-ablation remapping using EGF mapping.

  2. Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days

    Time frame: 7 days

    Freedom from Serious Adverse Events (SAE) related to the procedure through 7 days following the index procedure.

Secondary outcomes

  1. Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures

    Time frame: Index Procedure until Recurrence Procedure

    This measure represents the number of Electrographic Flow™ (EGF) identified sources that remained consistent in anatomical location during subsequent EGF-guided procedures. The number and anatomical locations of EGF-identified sources for each subject were compared between the Index procedure and a subsequent EGF-guided procedure conducted ≥ 3 months later. A source was considered consistent if it was visible in the same anatomical location across both procedures.

  2. 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. Follow-up and electrocardiographic monitoring of AF occurred at 3, 6 and 12 months through 7-day Holter recordings and ECGs.

  3. Average EGF Source Ablations Per Patient

    Time frame: During the procedure

    Average number of Electrographic Flow™ (EGF) source ablations per patients, defined as the number of significant EGF-identified sources with a source activity above threshold.

  4. Total Duration of EGF Source Ablation Per Patient

    Time frame: During the procedure

    Average total duration of radiofrequency ablation of the significant Electrographic Flow™ (EGF) identified sources per patient. Defined as the number of seconds of radiofrequency ablation spend on EGF-identified source ablation.

  5. Average Fluoroscopy Time Per Patient

    Time frame: During the procedure

    Average total fluoroscopy time (in minutes) of the complete electrophysiology procedure per patient.

  6. Total Radiation Dose Per Patient

    Time frame: During the procedure

    Average total radiation dose of the complete electrophysiology procedure, expressed in Air Kerma (AK) in mGy

  7. Total Procedure Time

    Time frame: During the procedure

    Total procedure time of complete electrophysiology procedure in minutes.

Sponsors and collaborators

Lead sponsor

Cortex

Industry

Collaborators

  • Ablacon, Inc.

Registry information

Official study title

A Randomized Controlled Study to Evaluate the Reliability of Electrographic Flow™ (EGF) Mapping Algorithm Technology to Identify Sources of Atrial Fibrillation and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation

Acronym: FLOW-AF

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2020
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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