Individually designed ablation of low-voltage areas in persistent atrial fibrillation-a randomized controlled trial (IDEAL-AF): study design and rationaleShow others and affiliations
2025 (English)In: European Heart Journal Open, E-ISSN 2752-4191, Vol. 5, no 2, article id oeaf037Article in journal (Refereed) Published
Abstract [en]
Aims Voltage-based ablation is a promising catheter ablation strategy for atrial fibrillation (AF) in which low-voltage zones (LVZs) are targeted as a complement to pulmonary vein isolation (PVI). In a randomized setting, we intend to investigate whether PVI plus ablation of LVZs, compared to PVI-only, decreases the incidence of arrhythmia recurrence and improves health-related quality of life (HRQoL) in patients with persistent AF and LVZs.Methods and results Individually designed ablation of low-voltage areas in persistent atrial fibrillation trial (IDEAL-AF; NCT04377594) is a multi-centre, randomized, controlled clinical trial. Patients with persistent AF and LVZs >= 3.0 cm(2) outside the PVI ablation lines will be randomized in a 1:1 ratio to either PVI or PVI plus LVZ ablation. The primary outcome will be the recurrence of atrial arrhythmias off anti-arrhythmic drugs during 12 months of follow-up after one to two ablation procedures within 6 months. A 3-month blanking period will be applied after the first procedure. Patients will be monitored using a smart phone-based ECG recording device throughout the follow-up period. With an anticipated enrolment of 936 patients, this study has 80% power to detect a 20% absolute risk reduction in the primary endpoint. Additionally, HRQoL improvement will be assessed using three questionnaires.Conclusion IDEAL-AF is a multi-centre, randomized, controlled clinical trial investigating whether ablation of LVZs in addition to PVI reduces the recurrence rate of atrial arrhythmias and improves HRQoL compared to PVI-only in patients with persistent AF and LVZs. This study has the potential to modify recommendations regarding ablation techniques for this specific patient cohort.
Place, publisher, year, edition, pages
OXFORD UNIV PRESS , 2025. Vol. 5, no 2, article id oeaf037
Keywords [en]
Low-voltage ablation; Persistent atrial fibrillation; Randomized study
National Category
Cardiology and Cardiovascular Disease
Identifiers
URN: urn:nbn:se:liu:diva-213590DOI: 10.1093/ehjopen/oeaf037ISI: 001477906600001PubMedID: 40303984OAI: oai:DiVA.org:liu-213590DiVA, id: diva2:1958254
Note
Funding Agencies|Swedish Research Council [2019-0097, 2021-00202]; Swedish Heart Lung foundation [20190301, 20200537, 20210302]; Center for Innovative Medicine [20190797]; ALF Stockholms laens landsting [FoUI-954075]; Ake Wibergs Stiftelse [M19-0424]
2025-05-142025-05-142025-05-14