Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60076658%3A12110%2F19%3A43899611" target="_blank" >RIV/60076658:12110/19:43899611 - isvavai.cz</a>
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S2405500X19303032?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2405500X19303032?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.jacep.2019.04.009" target="_blank" >10.1016/j.jacep.2019.04.009</a>
Alternative languages
Result language
angličtina
Original language name
Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial
Original language description
Objectives: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power–short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. Background: The vHPSD catheter is a novel contact force–sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. Methods: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. Results: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions—all classified as asymptomatic without clinical or neurologic deficits. Conclusions: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters.
Czech name
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Czech description
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Classification
Type
J<sub>SC</sub> - Article in a specialist periodical, which is included in the SCOPUS database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
JACC: Clinical Electrophysiology
ISSN
2405-5018
e-ISSN
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Volume of the periodical
5
Issue of the periodical within the volume
7
Country of publishing house
US - UNITED STATES
Number of pages
9
Pages from-to
778-786
UT code for WoS article
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EID of the result in the Scopus database
2-s2.0-85068253918