Email updates

Keep up to date with the latest news and content from BMC Cardiovascular Disorders and BioMed Central.

Open Access Study protocol

RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers

Harry JGM Crijns1*, Lori D Bash2, François Chazelle3, Jean-Yves Le Heuzey4, Thorsten Lewalter5, Gregory YH Lip6, Aldo P Maggioni7, Alfonso Martín8, Piotr Ponikowski9, Mårten Rosenqvist10, Prashanthan Sanders11, Mauricio Scanavacca12, Alexandra A Bernhardt13, Sreevalsa Unniachan14, Hemant M Phatak2 and Anselm K Gitt13

Author Affiliations

1 Maastricht University Medical Center, Maastricht, Netherlands

2 Merck & Co., Inc, Whitehouse Station, Readington, NJ, USA

3 Merck, Sharpe & Dohme, Paris, France

4 European Hospital Georges Pompidou, Rene Descartes University, Paris, France

5 University of Bonn, Bonn, Germany

6 University of Birmingham, Birmingham, UK

7 ANMCO Research Center, Florence, Italy

8 University Hospital Severo Ochoa, Madrid, Spain

9 Medical University, Wroclaw, Poland

10 Karolinska Institutet, Stockholm, Sweden

11 University of Adelaide, Adelaide, Australia

12 University of Sao Paulo, Sao Paulo, Brazil

13 Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany

14 UMDNJ School of Public Health, Piscataway, NJ, USA

For all author emails, please log on.

BMC Cardiovascular Disorders 2012, 12:85  doi:10.1186/1471-2261-12-85

Published: 2 October 2012

Abstract

Background

Atrial fibrillation is a serious public health problem posing a considerable burden to not only patients, but the healthcare environment due to high rates of morbidity, mortality, and medical resource utilization. There are limited data on the variation in treatment practice patterns across different countries, healthcare settings and the associated health outcomes.

Methods/design

RHYTHM-AF was a prospective observational multinational study of management of recent onset atrial fibrillation patients considered for cardioversion designed to collect data on international treatment patterns and short term outcomes related to cardioversion. We present data collected in 10 countries between May 2010 and June 2011. Enrollment was ongoing in Italy and Brazil at the time of data analysis. Data were collected at the time of atrial fibrillation episode in all countries (Australia, Brazil, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom), and cumulative follow-up data were collected at day 60 (±10) in all but Spain. Information on center characteristics, enrollment data, patient demographics, detail of atrial fibrillation episode, medical history, diagnostic procedures, acute treatment of atrial fibrillation, discharge information and the follow-up data on major events and rehospitalizations up to day 60 were collected.

Discussion

A total of 3940 patients were enrolled from 175 acute care centers. 70.5% of the centers were either academic (44%) or teaching (26%) hospitals with an overall median capacity of 510 beds. The sites were mostly specialized with anticoagulation clinics (65.9%), heart failure (75.1%) and hypertension clinics (60.1%) available. The RHYTHM-AF registry will provide insight into regional variability of antiarrhythmic and antithrombotic treatment of atrial fibrillation, the appropriateness of such treatments with respect to outcomes, and their cost-efficacy. Observations will help inform strategies to improve cardiovascular outcomes in patients with atrial fibrillation.

Trial registration

Clinical trials NCT01119716

Keywords:
Atrial fibrillation; Cardioversion; Heart failure; Stroke; Registry