Status:
COMPLETED
FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology
Lead Sponsor:
Cortex
Collaborating Sponsors:
Ablacon, Inc.
Conditions:
Atrial Fibrillation, Persistent
Eligibility:
All Genders
18-100 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04473963
Start Date
September 27 2019
End Date
September 27 2021
Last Update
April 10 2025
Active Locations (4)
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1
Nemocnice Na Homolce Hospital
Prague, Czech Republic, Czechia, 150 30
2
Practice Clinic Heart And Vessels
Dresden, Saxony Land, Germany, 01099
3
University Heart and Vascular Center Hamburg
Hamburg, Germany, 20246
4
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD