Abstract
Background: Electrographic flow (EGF) mapping enables the dynamic detection of functional or active atrial fibrillation (AF) sources outside the pulmonary veins (PVs), and the presence or absence of these sources offers a novel framework for classifying and treating persistent AF patients based on the underlying pathophysiology of their AF disease. Objective: The primary objective of the FLOW-AF trial is to evaluate the reliability of the EGF algorithm technology (Ablamap software) to identify AF sources and guide ablation therapy in patients with persistent AF. Methods: The FLOW-AF trial (NCT04473963) is a prospective, multicenter, randomized clinical study in which patients with persistent or long-standing persistent AF who have failed prior PV isolation (PVI) undergo EGF mapping after confirmation of intact PVI. In total, 85 patients will be enrolled and stratified based on the presence or absence of EGF-identified sources. Patients with an EGF-identified source above the predetermined activity threshold of ≥26.5% will be randomized in a 1:1 fashion to PVI only vs PVI + ablation of EGF-identified extra-PV sources of AF. Results: The primary safety endpoint is freedom from serious adverse events related to the procedure through 7 days following the randomization procedure; and the primary effectiveness endpoint is the successful elimination of significant sources of excitation with the target parameter the activity of the leading source. Conclusions: The FLOW-AF trial is a randomized study designed to evaluate the ability of the EGF mapping algorithm to identify patients with active extra-PV AF sources.
| Original language | English |
|---|---|
| Pages (from-to) | 391-400 |
| Number of pages | 10 |
| Journal | Heart Rhythm O2 |
| Volume | 4 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jun 2023 |
Bibliographical note
Funding Information:The FLOW-AF trial is funded by Ablacon (Wheat Ridge, CO). However, all data will be independently collected, managed, and analyzed with a restricted-access, Code of Federal Regulations–compliant database. The FLOW-AF Steering Committee includes the principal investigators (V.Y.R. and P.N) and the independent investigators listed as coauthors of the paper. The steering committee is responsible for the design and conduct of this study and will have full access to the final study data and statistical programming. Statistical assistance will be provided by third-party research statisticians. An independent Clinical Events Committee consisting of 2 cardiac electrophysiologists and 1 interventional cardiologist will be responsible for performing unbiased reviews and classification of serious adverse events reports by the clinical study investigators. None of the members of the Clinical Events Committee are participating in the FLOW-AF trial, and none have any significant investment in the Sponsor or any of their entities. Data monitoring and site management was performed by 2 independent contract research organizations in the Czech Republic (High Tech Med Consult, Prague, Czech Republic) and the Netherlands (Brommet Clinical Research, North Brabant, the Netherlands).
Funding Information:
The FLOW-AF trial was funded by Ablacon, Inc. Tamas Szili-Torok has a received a research grant and served as a consultant for Ablacon. Petr Neuzil has received grant funding from Ablacon and support from a Scientific Grant from the Ministry of Health Czech Republic, DRO (NNH, IG 180504). Jan Petru has received support from a Scientific Grant from the Ministry of Health Czech Republic, DRO (NNH, IG 180504). Moritoshi Funasako has received support from a Scientific Grant from the Ministry of Health Czech Republic, DRO (NNH, IG 180504). Leon Dinshaw has received speaker fees from Abbott. Andreas Rillig has received research and travel grants from Ablacon and travel grants from Abbott. Stefan G. Spitzer has received lecture grants from Abbott, Biotronik, Edwards, and Medtronic; advisory board and travel grants from Medtronic; and research grants from Ablacon, Medtronic, and Lifetech Scientific. Andreas Metzner has no relevant disclosures. Melissa H. Kong is an employee of and owns equity in Ablacon. Vivek Y. Reddy has served as a consultant for and owns equity in Ablacon; in addition, unrelated to this article, he has served as a consultant for and hownsas equity in Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare; unrelated to this work, he has served as a consultant for Abbott, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips, and Pulse Biosciences; and owns equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. The other authors have no conflicts of interest to disclose. All authors attest they meet the current ICMJE criteria for authorship. Written informed consent will be obtained from each patient prior to study inclusion. The research reported in this paper adheres to Helsinki Declaration guidelines. The study protocol received approval by the Ethics Committees at each institution prior to study enrollment.
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© 2023