N/A
N=80
FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology
Atrial Fibrillation, Persistent
Bottom Line
View on ClinicalTrials.gov: NCT04473963 ↗Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Acute Procedure Success — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrographic Flow™ guided ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cortex
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Procedure Success |
19 | — |
| PRIMARY Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days |
0; 0; 2; 2 | 0.277 |
| SECONDARY Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures |
16 | — |
| SECONDARY Number of Participants With 12-month Freedom From AF Recurrence |
13; 6; 17 | 0.042 sig |
| SECONDARY Average EGF Source Ablations Per Patient |
3.05 | — |
| SECONDARY Total Duration of EGF Source Ablation Per Patient |
10.18 | — |
| SECONDARY Average Fluoroscopy Time Per Patient |
15.1; 10.8; 13.8 | — |
| SECONDARY Total Radiation Dose Per Patient |
155; 143; 186 | — |
| SECONDARY Total Procedure Time |
183; 107; 137.2 | <0.001 sig |
Summary
This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04473963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.