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Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results
RR. Tilz, GB. Chierchia, M. Gunawardene, P. Sanders, H. Haqqani, J. Kalman, S. Healy, H. Pürerfellner, P. Neuzil, JO. Asensi, P. Loh, VY. Reddy, S. Knecht, E. Jesser, N. Dirckx, A. Miller, D. Walker, D. Lakkireddy
Jazyk angličtina
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
Grantová podpora
Abbott
Investigator Grant Fellowships
National Health and Medical Research Council of Australia
NLK
PubMed Central
od 2008
Open Access Digital Library
od 1999-01-01
Medline Complete (EBSCOhost)
od 1999-01-01
Oxford Journals Open Access Collection
od 1999-01-01
PubMed
40163671
DOI
10.1093/europace/euaf072
Knihovny.cz E-zdroje
- MeSH
- časové faktory MeSH
- fibrilace síní * chirurgie patofyziologie diagnóza MeSH
- katetrizační ablace * přístrojové vybavení škodlivé účinky metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- recidiva MeSH
- senioři MeSH
- venae pulmonales * chirurgie patofyziologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
AIMS: Pulsed field ablation (PFA) is a growing ablation modality for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. This study assesses the 6-month safety and effectiveness of a novel balloon-in-basket, mapping-integrated PFA system, with a purpose-built form factor for PVI. METHODS AND RESULTS: The VOLT CE Mark Study is a prospective, multi-center, pre-market study. A total of 150 patients with drug-refractory paroxysmal (PAF) or persistent AF (PersAF) were enrolled between 8 November 2023 and 14 March 2024, of which 146 patients (age 64.1 ± 10.0 years, 63.0% male, 70.5% PAF) underwent PVI with the balloon-in-basket PFA catheter and system featuring integrated electroanatomic mapping with contact-sensing. Study endpoints were the rate of primary serious adverse events within 7 days as well as acute procedural effectiveness and 6-month freedom from recurrence. Acute effectiveness was achieved in 99.1% (573/578) of treated PVs (98.6% of patients, 144/146) with 17.6 ± 5.7 PFA applications/patient. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 100.4 ± 33.0, 17.3 ± 12.1, 39.4 ± 20.6, and 31.4 ± 16.8 min, respectively. There were 4 (2.7%; 4/146) primary serious adverse events. The rate of freedom from documented atrial arrhythmias was 88.2% in PAF patients and 76.7% in PersAF patients (freedom from symptomatic recurrence was documented in 90.2% of PAF patients and 74.4% of PersAF patients) through 6-months post-index procedure. CONCLUSION: The VOLT CE Mark Study primary results demonstrate the safety and effectiveness of the novel balloon-in-basket PFA system to perform PVI in PAF and PersAF.
Cardiology Department Nemocnice Na Homolce Roentgenova 37 150 00 Praha 5 Czechia
Department of Cardiology and Intensive Care Medicine Asklepios Hospital St Georg Hamburg Germany
Department of Cardiology AZ Sint Jan Ruddershove 10 8000 Brugge Belgium
Department of Cardiology The Prince Charles Hospital 627 Rode Rd Chermside QLD 4032 Australia
Department of Cardiology UMC Utrecht Heidelberglaan 100 Utrecht 3584 CX Netherlands
Electrophysiology Abbott Minneapolis MN USA
German Center for Cardiovascular Research Partner Site Hamburg Kiel Lübeck Lübeck Germany
Heart Rhythm Management Center UZ Brussels Vrij Universiteit Brussel Brussels Belgium
Mount Sinai Fuster Heart Hospital One Gustave L Levy Medical Place New York New York 10029 USA
Citace poskytuje Crossref.org
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