Routine use of a 3D mapping system in the ablation of supraventricular arrhythmias with as low as reasonably achievable X-ray exposure (AALARA): protocol for a prospective, observational, multicentre, multinational, open-label registry study.
| Autor: | Szegedi N; Semmelweis University Heart and Vascular Centre, Budapest, Hungary., Kroptkin E; Federal Center for Cardiovascular Surgery, Krasnoyarsk region, Russian Federation., Traykoc V; Federal Center for Cardiovascular Surgery, Krasnoyarsk region, Russian Federation., Abdrakhmanov A; Acibadem City Clinic Tokuda Hospital, Sofia, Bulgaria., Lorgat F; Christian Barnard Memorial Hospital, Cape Town, South Africa., Sapelnikov O; Institute of Clinical Cardiology, Moscow, Russian Federation., Simons S; CRO Dr med Kottmann GmbH & Co. KG, Hamm, Germany., Amin M; Cardiology, Mohammed bin Khalifa bin Salman Al Khalifa Specialist Cardiac Centre, Awali, Bahrain drmohdamin@gmail.com. |
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| Jazyk: | angličtina |
| Zdroj: | BMJ open [BMJ Open] 2023 Aug 04; Vol. 13 (8), pp. e072181. Date of Electronic Publication: 2023 Aug 04. |
| DOI: | 10.1136/bmjopen-2023-072181 |
| Abstrakt: | Introduction: The reduction of fluoroscopic exposure during catheter ablation of supraventricular arrhythmias is widely adopted by experienced electrophysiology physicians with a relatively short learning curve and is becoming standard of care in many parts of the world. While observational studies in the USA and some parts of Western Europe have evaluated the minimal fluoroscopic approach, there are scarce real-world data for this technique and generalisability of outcome in other economic regions. Methods and Analysis: The arrhythmias with as low as reasonably achievable X-ray exposure study is a prospective, observational, multicentre and multinational open-label registry study. Up to 700 patients undergoing catheter ablation for right-sided supraventricular arrhythmias (according to national guidelines) will be enrolled for the routine use of the EnSite Precision 3D mapping system. Participating sites are distributed in 13 countries from Central Eastern Europe, North and South Africa, the Middle East and the CIS (Commonwealth of Independent States), with different levels of expertise using minimal fluoroscopic exposure techniques. After electrophysiological procedure, patients will be followed up for 6 months either in-clinic or via telephone interview. Patients will be asked to complete a study questionnaire at enrolment and 6 months after the invasive procedure to assess quality of life changes secondary to the procedure. The study's primary objective is to describe ionising radiation exposure during catheter ablation when the EnSite Precision 3D mapping system is used in supraventricular tachycardia ablation. The study's secondary objective is to assess the safety and efficacy of this method. Furthermore, fluoroscopy timing, total procedure time, success rate and complications will be reported. Ethics and Dissemination: The study was approved by the ethics committee at Mohammed Bin Khalifa Specialist Cardiac Centre (BDF/R&REC/2020-504) and the medical ethics committees of all participating sites. Participants will be required to provide informed consent before enrolment in the study. The study results will be published and presented at conferences. Trial Registration Number: NCT04716270. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Databáze: | MEDLINE |
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