Registries and surveys have been conducted in patients with AFib to determine the epidemiological aspects of the disease
Background and rationale Atrial Fibrillation (AFib) is associated with a reduced quality of life and increasing healthcare costs in both US and Europe RR 3 2,5 2 1,5 1 0,5 FRAMINGAHN RP MARSHFIELD
Background and rationale Recent advances in non-pharmacological therapy have proved effective and an increasing number of centres are performing AFib ablation
Background and rationale A survey able to capture all the relevant clinical and procedural information of patients undergoing AFib ablation could allow to improve our knowledge on epidemiology and outcomes of real world patients with this clinical condition
Study design Prospective, multicentre, multinational, observational survey of consecutive patients undergoing a first AFib ablation procedure in about 100 Cardiology Centres in 11 European countries Site selection will target hospitals with a medium to high expertise in performing a minimum of 50 AFib ablation procedures/year For this specific Pilot phase, 20 consecutive patients undergoing a first AFib ablation procedure will be enrolled per centre and followed up for 1 year
Objectives of the survey To describe the demographic, clinical, and biological characteristics of patients undergoing a first AFib ablation procedure in a representative setting of European cardiology centres To describe the diagnostic and therapeutic approaches undertaken in the routine practice of cardiologists performing AFib ablation procedures To assess the acute and chronic outcomes of patients undergoing AFib ablation procedures To assess the short and long term safety/complications of the procedure
Objectives of the survey To assess how the participating centers evaluate, in routine clinical practice, the success of the procedure during the follow-up To evaluate how the recommendations of the most recent European guidelines are adopted in clinical practice Moreover, the Pilot phase is aimed at validating structure, performance, feasibility of this observational study and quality of the data-set, with the intention of continuing the Survey in a larger number of centers
Study population All consecutive patients scheduled for a first AFib ablation procedure in the participating centers during the enrollment period will be included up to a number of 20 patients No data will be collected before detailed information is given to the patient and a signed informed consent is obtained (according to the different national rules) No specific exclusion criteria are foreseen
Procedures Data will be collected using a web based system Drug prescriptions and the indications to perform diagnostic/therapeutic procedures will be completely left to the decisions of the participating cardiologists No specific protocols, or recommendations for the procedure itself, management, and/or treatment after the procedure will be put forth during this observational study Centers must plan their follow-up procedures according to their usual clinical practice and report the information on the ad-hoc follow-up CRFs Follow up information will be collected for all patients after 12 months from the procedure
Statistical considerations and sample size All patients enrolled will be included in the analysis Descriptive summaries will be presented for all the patients, and for subgroups of patients Statistical tests may be carried out for exploratory purposes, as appropriate Multivariable analyses may be used to explore relationship between baseline covariates and endpoints, as appropriate
Statistical considerations and sample size Being the study fully observational, a formal sample size was not calculated A minimum of 2000 consecutive patients is estimated as needed to make an experience solid enough to judge the quality of the study and the possible need of operational changes to the protocol to obtain a preliminary European profile of patients undergoing an AFib ablation procedure according to the collected information listed above
Study Committees Executive Committee Josep Brugada, Chairperson Gerhard Hindriks Aldo Maggioni (non voting member) John Morgan Luigi Tavazzi (Oversight Committee) Panos Vardas Steering Committee Josep Brugada (Chairman) National Coordinators (designated by the National Societies) from: France, Italy, Germany, Spain, Greece, The Netherlands, Belgium, Denmark, Czech Republic, Poland, United Kingdom
ATRIAL FIBRILLATION ABLATION REGISTRY National Coordinators BE CZ DE DK FR GR IT NL PL SP UK Georges Mairesse Milos Taborsky / Josef Kautzner Thorsten Lewalter Sam Riahi Pierre Jais / Frédéric Anselme Georges Theodorakis Giuseppe Inama Serge Trines Zbigniew Kalarus Julian Perez Villacastin Mauro Lencioni
European Society of Cardiology Coordinating Centre EURObservational Research Department Project Coordination, Scientific Secretariat and Data Management Team: Emanuela Fiorucci, Assistant Cécile Laroche, Data Monitor Malika Manini, Head of Department Charles Taylor, Data Monitor & IT specialist Aldo P. Maggioni, Board consultant for the EURObservational Research Programme
Ethical issues The National Coordinator in conjunction with the local investigators will be responsible for obtaining the approval of the local and national review boards for this survey, if necessary The EURObservational Research Department of the ESC will distribute the relevant documents in English to the National Coordinator, who will be responsible thereafter for its translation and adaptation to local standards All patients will be approached by the local centre investigator and will be asked for their written informed consent to participate in the survey (if necessary, i.e. based on local standards)
Duration of the survey Starting recruitment in October 2010 and ending in April 2011 Follow up information will be collected for all patients after 12 months from the procedure The last patient last visit should be conducted by the end of April 2012