Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216305%3A26220%2F22%3APU147358" target="_blank" >RIV/00216305:26220/22:PU147358 - isvavai.cz</a>

Alternative codes found

RIV/65269705:_____/22:00076069 RIV/00064173:_____/22:43923666 RIV/00064165:_____/22:10444722 RIV/00216208:11110/22:10444722 and 3 more

Result on the web

<a href="https://bmjopen.bmj.com/content/bmjopen/12/6/e056522.full.pdfb" target="_blank" >https://bmjopen.bmj.com/content/bmjopen/12/6/e056522.full.pdfb</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/bmjopen-2021-056522" target="_blank" >10.1136/bmjopen-2021-056522</a>

Result language

angličtina

Original language name

Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)

Original language description

Introduction Atrial fibrillation (AF), with a prevalence of 2%, is the most common cardiac arrhythmia. Catheter ablation (CA) has been documented to be superior to treatment by antiarrhythmic drugs (AADs) in terms of sinus rhythm maintenance. However, in obese patients, substantial weight loss was also associated with AF reduction. So far, no study has compared the modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA) treatment. The aim of the trial is to compare the efficacy of modern invasive (CA) and non-invasive (AADs with risk factor management) treatment of AF. Methods and analysis The trial will be a prospective, multicentre, randomised non-inferiority trial. Patients with symptomatic AF and a body mass index >30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio. In the CA arm, pulmonary vein isolation (in combination with additional lesion sets in non-paroxysmal patients) will be performed. For patients in the RFM+AAD arm, the aim will be a 10% weight loss over 6-12 months, increased physical fitness and a reduction in alcohol consumption. The primary endpoint will be an episode of AF or regular atrial tachycardia lasting >30s. The secondary endpoints include AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints. An AF freedom of 65% in the RFM+AAD and of 60% in the CA is expected; therefore, 202 patients will be enrolled to achieve the non-inferiority with 80% power, 5% one-sided alpha and a non-inferiority margin of 12%. Ethics and dissemination The PRAGUE-25 trial will determine if modern non-invasive AF treatment strategies are non-inferior to CA. The study was approved by the Ethics Committee of the University Hospital Kralovske Vinohrady. Results of the study will be disseminated on scientific conferences and in peer-reviewed scienti

Czech name

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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

30200 - Clinical medicine

Project

<a href="/en/project/NU21-02-00388" target="_blank" >NU21-02-00388: Catheter Ablation vs. Risk Factor Modification</a><br>

Continuities

S - Specificky vyzkum na vysokych skolach

Publication year

2022

Confidentiality

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

Name of the periodical

BMJ Open

ISSN

2044-6055

e-ISSN

—

Volume of the periodical

12

Issue of the periodical within the volume

6

Country of publishing house

GB - UNITED KINGDOM

Number of pages

8

Pages from-to

1-8

UT code for WoS article

000812378000015

EID of the result in the Scopus database

2-s2.0-85132192313