A Novel Visually Guided Radiofrequency Balloon Ablation Catheter for Pulmonary Vein Isolation One-Year Outcomes of the Multicenter AF-FICIENT I Trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F21%3A00009104" target="_blank" >RIV/00023884:_____/21:00009104 - isvavai.cz</a>
Result on the web
<a href="https://www.ahajournals.org/doi/full/10.1161/CIRCEP.120.009308" target="_blank" >https://www.ahajournals.org/doi/full/10.1161/CIRCEP.120.009308</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1161/CIRCEP.120.009308" target="_blank" >10.1161/CIRCEP.120.009308</a>
Alternative languages
Result language
angličtina
Original language name
A Novel Visually Guided Radiofrequency Balloon Ablation Catheter for Pulmonary Vein Isolation One-Year Outcomes of the Multicenter AF-FICIENT I Trial
Original language description
BACKGROUND: A multielectrode saline-irrigated radiofrequency (RF) balloon catheter with an integrated camera system was designed to perform single-shot pulmonary vein (PV) isolation. To optimize ablation, simultaneous circumferential RF energy can be delivered, albeit with power output that is tailored to individual electrodes based on direct visualization of tissue-electrode contact. In a first-in-human multicenter clinical trial, we studied the feasibility, performance, safety, and efficacy of PV isolation using this novel ablation catheter to treat atrial fibrillation. METHODS: AF-FICIENT-I was a prospective, 5-center, single-arm study. After transseptal puncture, the RF balloon was positioned over the wire at each pulmonary (PV) ostium using a 13.3F sheath. RF energy was titrated based on visual contact (6-10 W; up to 60 seconds per ablation). Electrical PV isolation was confirmed using either, (1) sensing mini-electrodes situated on the RF balloon itself or (2) a circular mapping catheter. Patients were clinically assessed for recurrent atrial arrhythmias lasting >30 s over 12 months, after a 3-month blanking period. RESULTS: Six operators performed de novo PV isolation in 99 patients (95 paroxysmal/4 persistent; age, 58 +/- 11; men, 67.7%). Median times, including procedure, fluoroscopy, ablation (time from first RF to last RF application), and balloon (time elapsing between catheter introduction to removal from the body) times, were 85 (interquartile range, 62-118), 14 (interquartile range, 9-23), 31 (interquartile range, 20-53), and 43 minutes (interquartile range, 32-70), respectively. The 12-month Kaplan-Meier estimates of freedom from any atrial arrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) or atrial fibrillation alone were 77.5% (95% CI, 67.6%-84.7%) and 84.1% (95% CI, 74.9%-90.1%), respectively. There were no device-related serious adverse events.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Circulation-Arrhythmia and Electrophysiology
ISSN
1941-3149
e-ISSN
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Volume of the periodical
14
Issue of the periodical within the volume
10
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
919-928
UT code for WoS article
000708617400006
EID of the result in the Scopus database
2-s2.0-85119458302