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

Kód výsledku v 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>

Nalezeny alternativní kódy

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

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

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

Popis výsledku anglicky

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

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2021

Kód důvěrnosti údajů

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

Název periodika

JACC Clinical Electrophysiology

ISSN

2405-500X

e-ISSN

—

Svazek periodika

7

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

12

Strana od-do

352-363

Kód UT WoS článku

000629482200008

EID výsledku v databázi Scopus

2-s2.0-85100647893