A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F21%3A00080800" target="_blank" >RIV/00023001:_____/21:00080800 - isvavai.cz</a>

Alternative codes found

RIV/00159816:_____/21:00074697 RIV/00023884:_____/21:00009069

Result on the web

<a href="https://reader.elsevier.com/reader/sd/pii/S2405500X20311907?token=F3476426BC5F554AD40D241979293135DC771660BEAC0AE80FE29221909D6475357F7A39E09A866DE1E3B6D5FB733F15" target="_blank" >https://reader.elsevier.com/reader/sd/pii/S2405500X20311907?token=F3476426BC5F554AD40D241979293135DC771660BEAC0AE80FE29221909D6475357F7A39E09A866DE1E3B6D5FB733F15</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jacep.2020.11.009" target="_blank" >10.1016/j.jacep.2020.11.009</a>

Result language

angličtina

Original language name

A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation

Original language description

Objectives: DIAMOND-AF (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation) was a prospective, multicenter, noninferiority, randomized trial that compared the safety and effectiveness of the DTA system versus those of a force-sensing RF ablation system (control) for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF). Background: Irrigated radiofrequency (RF) ablation catheters lose tissue temperature acuity, which is vital in assessing lesion formation. DiamondTemp Ablation (DTA) was designed to re-establish accurate tissue temperature measurements during ablation. Methods: A total of 482 patients with paroxysmal AF were randomized (239 DTA, 243 control) to undergo pulmonary vein isolation and were followed up at 23 sites. Patients were screened for disease progression, cardiac characteristics, and prior interventions. Primary endpoints were effectiveness (freedom from atrial arrhythmia recurrence) and safety (composite of procedure- and device-related serious adverse events). Results: The primary safety event rate was 3.3% in the DTA group versus 6.6% in the control group (p &lt; 0.001 vs. 6.5% noninferiority margin). Primary effectiveness was met in 79.1% of DTA subjects and 75.7% of control subjects (p &lt; 0.001 vs. -12.5% noninferiority margin). Secondary endpoint analysis found that off-drug effectiveness favored DTA compared with the control (142 [59.4%] vs. 120 [49.4%], respectively; p = 0.03). Total RF time and individual RF ablation duration were significantly shorter with less saline infused through the DTA catheter (p &lt; 0.001). Both arms saw clinically meaningful improvements in quality of life at 12 months. Conclusions: Safety and efficacy of the DTA system proved noninferior to force-sensing RF ablation in a paroxysmal AF population. Efficiencies were observed using DTA with shorter total RF times, individual RF ablation durations, and less saline infusion. (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation; NCT03334630) © 2021 The Authors

Czech name

—

Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2021

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

JACC Clinical Electrophysiology

ISSN

2405-500X

e-ISSN

—

Volume of the periodical

7

Issue of the periodical within the volume

3

Country of publishing house

US - UNITED STATES

Number of pages

12

Pages from-to

352-363

UT code for WoS article

000629482200008

EID of the result in the Scopus database

2-s2.0-85100647893