Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)
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 a...
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BMJ Publishing Group
2022-06-01
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| author | Stepan Havranek Jiri Jarkovsky Otakar Jiravský Pavel Osmancik Veronika Bulková Jan Chovančík Tomáš Roubíček Dalibor Heřman Zuzana Čarná Vladimír Tuka Martin Matoulek Martin Fiala Sylvie Stregl-Hruskova Adam Latiňák Jiřina Kotryová |
| author_facet | Stepan Havranek Jiri Jarkovsky Otakar Jiravský Pavel Osmancik Veronika Bulková Jan Chovančík Tomáš Roubíček Dalibor Heřman Zuzana Čarná Vladimír Tuka Martin Matoulek Martin Fiala Sylvie Stregl-Hruskova Adam Latiňák Jiřina Kotryová |
| author_sort | Stepan Havranek |
| collection | DOAJ |
| 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 >30 s. 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 scientific journals. After the end of follow-up, data will be available upon request to principal investigator.Trial registration number ClinicalTrials.gov Registry (NCT04011800). |
| format | Article |
| id | doaj-art-68e543e880c940ad966355ca0c2a884d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
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| spelling | doaj-art-68e543e880c940ad966355ca0c2a884d2025-01-28T09:15:13ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-056522Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)Stepan Havranek0Jiri Jarkovsky1Otakar Jiravský2Pavel Osmancik3Veronika Bulková4Jan Chovančík5Tomáš Roubíček6Dalibor Heřman7Zuzana Čarná8Vladimír Tuka9Martin Matoulek10Martin Fiala11Sylvie Stregl-Hruskova12Adam Latiňák13Jiřina Kotryová142 2nd Department of Internal Cardiovascular Medicine, General University Hospital in Prague, Praha, Czech Republic4 Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech RepublicDepartment of Cardiology, Charles University, Prague, Czech RepublicDepartment of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech RepublicDepartment of Cardiology, University Hospital Brno, Brno, Czech RepublicDepartment of Cardiology, Charles University, Prague, Czech RepublicDepartment of Cardiology, Regional Hospital Liberec, Liberec, Czech RepublicDepartment of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech RepublicDepartment of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech RepublicCardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Prague, Czech RepublicThird Internal Department of Endocrinology and Metabolism, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech RepublicDepartment of Cardiology, University Hospital Brno, Brno, Czech RepublicDepartment of Cardiology, Regional Hospital Liberec, Liberec, Czech RepublicDepartment of Cardiology, Regional Hospital Liberec, Liberec, Czech RepublicMasaryk University, Brno, Czech RepublicIntroduction 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 >30 s. 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 scientific journals. After the end of follow-up, data will be available upon request to principal investigator.Trial registration number ClinicalTrials.gov Registry (NCT04011800).https://bmjopen.bmj.com/content/12/6/e056522.full |
| spellingShingle | Stepan Havranek Jiri Jarkovsky Otakar Jiravský Pavel Osmancik Veronika Bulková Jan Chovančík Tomáš Roubíček Dalibor Heřman Zuzana Čarná Vladimír Tuka Martin Matoulek Martin Fiala Sylvie Stregl-Hruskova Adam Latiňák Jiřina Kotryová Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) BMJ Open |
| title | Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) |
| title_full | Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) |
| title_fullStr | Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) |
| title_full_unstemmed | Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) |
| title_short | Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) |
| title_sort | catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation a protocol of a randomised controlled trial prague 25 trial |
| url | https://bmjopen.bmj.com/content/12/6/e056522.full |
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