Trials / Completed
CompletedNCT04473963
FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Cortex · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2019-09-27
- Primary completion
- 2021-09-27
- Completion
- 2021-09-27
- First posted
- 2020-07-16
- Last updated
- 2025-04-10
- Results posted
- 2025-01-29
Locations
4 sites across 3 countries: Czechia, Germany, Netherlands
Source: ClinicalTrials.gov record NCT04473963. Inclusion in this directory is not an endorsement.