Randomized, controlled trial of the safety and effectiveness of a contact force-sensing irrigated catheter for ablation of paroxysmal atrial fibrillation results of the TactiCath contact force ablation catheter study for atrial fibrillation (TOCCASTAR) study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F15%3A00059516" target="_blank" >RIV/00023001:_____/15:00059516 - isvavai.cz</a>

Result on the web

<a href="http://circ.ahajournals.org/content/132/10/907.full.pdf+html" target="_blank" >http://circ.ahajournals.org/content/132/10/907.full.pdf+html</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1161/CIRCULATIONAHA.114.014092" target="_blank" >10.1161/CIRCULATIONAHA.114.014092</a>

Result language

angličtina

Original language name

Randomized, controlled trial of the safety and effectiveness of a contact force-sensing irrigated catheter for ablation of paroxysmal atrial fibrillation results of the TactiCath contact force ablation catheter study for atrial fibrillation (TOCCASTAR) study

Original language description

Background Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation. Methods and Results A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins were isolated in both groups. Effectiveness was achieved in 67.8% and 69.4% of subjects in the CF and control arms, respectively (absolute difference, -1.6%; lower limit of 1-sided 95% confidence interval, -10.7%; P=0.0073 for noninferiority). When the CF arm was stratified into optimal CF (90% ablations with 10 g) and nonoptimal CF groups, effectiveness was achieved in 75.9% versus 58.1%, respectively (P=0.018). The primary safety end point occurred in 1.97% and 1.40% of CF patients and control subjects, respectively (absolute difference, 0.57%; upper limit of 1-sided 95% confidence interval, 3.61%; P=0.0004 for noninferiority). Conclusions The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. Clinical Trial Registration http://www.clinicaltrials.gov. Unique identifier: NCT01278953.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FA - Cardiovascular diseases including cardio-surgery

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2015

Confidentiality

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

Name of the periodical

Circulation

ISSN

0009-7322

e-ISSN

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Volume of the periodical

132

Issue of the periodical within the volume

10

Country of publishing house

US - UNITED STATES

Number of pages

9

Pages from-to

907-915

UT code for WoS article

000361110300003

EID of the result in the Scopus database

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