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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2021-09-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation

NCT05481359

Atrial Fibrillation, Persistent Atrial Fibrillation Arrhythmias, Cardiac +1 more

COMPLETED

FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation

NCT06260670

Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation Atrial Fibrillation, Persistent +1 more

COMPLETED NA

Utilizing a Novel Method to Map Sources of Atrial Fibrillation

NCT02523534

Atrial Fibrillation

COMPLETED NA

Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

NCT01765075

Permanent Atrial Fibrillation

COMPLETED

Non Invasive Mapping Before Ablation for Atrial Fibrillation.

NCT02113761

Atrial Fibrillation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation, Persistent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Randomized to Treatment: PVI + Electrographic Flow™ (EGF) Guided Ablation Therapy

This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization.

Subjects randomized to the "treatment" group first received pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. After this, EGF mapping in AF was conducted and targeted radiofrequency ablation of EGF-identified source(s) was performed in the left and right atrium. The procedure is considered complete once all EGF-identified sources have been eliminated through ablation. If necessary, the procedure were concluded with cardioversion.

Group Type EXPERIMENTAL

Electrographic Flow™ guided ablation

Intervention Type DEVICE

In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF).

EGF mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF software. Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity above the threshold (≥ 26.5%) are considered significant and targeted for ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.

Randomized to Control: PVI Only

This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, and exhibited EGF-identified significant sources with leading source activity above threshold (≥26.5%), qualifying them for randomization.

Subjects randomized to the "control" group received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Subjects also received EGF mapping while in AF, but no further ablation of the EGF-identified sources. The procedure were concluded with cardioversion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Not Randomized

This arm includes subjects who underwent Electrographic Flow™ (EGF) mapping, but exhibited no EGF-identified sources with leading source activity above threshold (≥26.5%).

Subjects received standard pulmonary vein isolation (PVI) or PVI touch-up followed by a 20 minute waiting period and PVI confirmation. Empiric adjunctive ablation could be performed at operator discretion. If necessary, the procedure were concluded with cardioversion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrographic Flow™ guided ablation

In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF).

EGF mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF software. Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity above the threshold (≥ 26.5%) are considered significant and targeted for ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Electrographic Flow™ Mapping Technology OptiMap™ Ablamap®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No