Clinical trial NCT04473963: FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Lead sponsor: Cortex
Sponsor class: INDUSTRY
Collaborators: name: Ablacon, Inc.
First posted: 2020-07-16
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will receive Electrographic Flow™ (EGF) mapping with Ablamap® Software. If EGF mapping identifies a source with a source activity level above threshold (≥26.5%) the subjects will be randomized to "treatment" or "control". If EGF mapping detects no source above threshold the subject will fall into the "not randomized" arm.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Acute Procedure Success
timeFrame: During the Procedure
measure: Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days
timeFrame: 7 days
Secondary outcomes:
measure: Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures
timeFrame: Index Procedure until Recurrence Procedure
measure: Number of Participants With 12-month Freedom From AF Recurrence
timeFrame: 90 day - 12 months
measure: Average EGF Source Ablations Per Patient
timeFrame: During the procedure
measure: Total Duration of EGF Source Ablation Per Patient
timeFrame: During the procedure
measure: Average Fluoroscopy Time Per Patient
timeFrame: During the procedure
measure: Total Radiation Dose Per Patient
timeFrame: During the procedure
measure: Total Procedure Time
timeFrame: During the procedure
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Nemocnice Na Homolce Hospital
state: Czech Republic
city: Dresden
country: Germany
facility: Practice Clinic Heart And Vessels
state: Saxony Land
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Principal Investigator - Czech Republic
name: Petr Neuzil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Principal Investigator - The Netherlands
name: Tamas Szili-Torok, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Principal Investigator - Germany
name: Stefan Spitzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reddy VY, Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P. A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). JACC Clin Electrophysiol. 2024 Aug;10(8):1856-1869. doi: 10.1016/j.jacep.2024.03.040. Epub 2024 Jun 5.