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

Not Applicable

Completed

• Conditions: Atrial Fibrillation, Persistent
• Interventions: Device: Ablamap Software

• Registration Number: NCT04473963
• Lead Sponsor: Cortex

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Results First Submitted: 2024-02-09
• Results First Submitted QC: 2024-12-13
• Results First Posted: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Suitable candidate for intra-cardiac mapping and ablation of atrial 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, persistent or longstanding persistent atrial fibrillation < 36 months.
4. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
5. Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to De Novo subjects)

Exclusion Criteria

1. Left atrial diameter > 5.5 cm.
2. Left ventricular ejection fraction (LVEF) < 35%.
3. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
4. Coagulopathy, bleeding diathesis or suspected procoagulant state.
5. 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.
6. Positive pregnancy test results for female patients of childbearing potential or breast feeding.
7. 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.
8. Mitral valve stenosis and/or severe mitral regurgitation.
9. Valvular atrial fibrillation.
10. Prosthetic valves.
11. New York Heart Association (NYHA) Class IV.
12. History of myocardial infarction (MI) within 3 months prior to procedure.
13. Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
14. Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
15. Life expectancy < 12 months based on medical history or the medical judgement of the investigator.
16. Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGF-Guided Ablation Therapy	Ablamap Software	Subjects randomized to "therapy" will be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Procedure Success	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.
Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days	7 days	Freedom from Serious Adverse Events (SAE) related to the procedure through 7 days following the index procedure.

Secondary Outcome Measures

Name	Time	Method
Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures	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.
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. Follow-up and electrocardiographic monitoring of AF occurred at 3, 6 and 12 months through 7-day Holter recordings and ECGs.
Average EGF Source Ablations Per Patient	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.
Total Duration of EGF Source Ablation Per Patient	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.
Average Fluoroscopy Time Per Patient	During the procedure	Average total fluoroscopy time (in minutes) of the complete electrophysiology procedure per patient.
Total Radiation Dose Per Patient	During the procedure	Average total radiation dose of the complete electrophysiology procedure, expressed in Air Kerma (AK) in mGy
Total Procedure Time	During the procedure	Total procedure time of complete electrophysiology procedure in minutes.

Trial Locations

Locations (4)

Practice Clinic Heart And Vessels; 🇩🇪 Dresden, Saxony Land, Germany

University Heart and Vascular Center Hamburg; 🇩🇪 Hamburg, Germany

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Nemocnice Na Homolce Hospital; 🇨🇿 Prague, Czech Republic, Czechia