FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology

  • STATUS
    Recruiting
  • days left to enroll
    6
  • participants needed
    100
  • sponsor
    Ablacon, Inc.
Updated on 24 January 2021
Investigator
Patty Hevey
Primary Contact
Nemocnice Na Homolce Hospital (1.2 mi away) Contact
arrhythmia
cardiac mapping

Summary

This study is to evaluate the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap Software).

Description

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

Details
Condition Atrial Fibrillation, Persistent, Atrial Fibrillation, Persistent, Atrial Fibrillation, Persistent
Treatment Ablamap Software
Clinical Study IdentifierNCT04473963
SponsorAblacon, Inc.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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 within the past 36 months with ablation therapy presenting with recurrent symptoms of AF

Exclusion Criteria

LA diameter > 5.5 cm
Left ventricular ejection fraction (LVEF) < 40%
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
NYHA Class IV
History of 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
Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads or pacemaker implant procedure
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