Clinical trial NCT01119716: International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
Official title: International Registry on Cardioversion of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Afib
cardioversion
normal sinus rhythm
arrhythmia
AF
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Institut für Herzinfarktforschung an der Universität Heidelberg
First posted: 2010-05-07
Enrollment: 4658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in a hospital setting in Australia, Brazil, France, Germany, Italy, Netherlands, Poland, UK, Spain, and Sweden from a cross section of different centers including university and non-university hospitals.

Brief summary: This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the characterization of type of Afib, as well as on treatments applied (drugs, devices, interventions and their combinations), and associated complications within 60 days after enrollment.


Eligibility criteria: Inclusion Criteria:

* Participant with documented atrial fibrillation (confirmed by electrocardiogram) in the hospital setting at the time of enrollment
* Planned cardioversion (of atrial fibrillation)

Exclusion Criteria:

* Already enrolled in this or any other clinical trial
* Atrial flutter

Primary outcomes:
measure: Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
timeFrame: Baseline (time of admission)
measure: Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
timeFrame: Baseline (time of admission)
measure: Clinical Type of Atrial Fibrillation at Baseline (Admission)
timeFrame: Baseline (time of admission)
measure: Treatments Utilized for Participants for Atrial Fibrillation
timeFrame: At time of Treatment (up to 1 day from admission)
measure: Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion
timeFrame: At time of treatment (up to 1 day from admission)
measure: Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
timeFrame: up to 60 days from day of treatment (cardioversion)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Crijns HJ, Weijs B, Fairley AM, Lewalter T, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bash LD, Chazelle F, Bernhardt A, Gitt AK, Lip GY, Le Heuzey JY. Contemporary real life cardioversion of atrial fibrillation: Results from the multinational RHYTHM-AF study. Int J Cardiol. 2014 Apr 1;172(3):588-94. doi: 10.1016/j.ijcard.2014.01.099. Epub 2014 Jan 25.
citation: Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, Lewalter T, Lip GY, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bernhardt AA, Unniachan S, Phatak HM, Gitt AK. RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers. BMC Cardiovasc Disord. 2012 Oct 2;12:85. doi: 10.1186/1471-2261-12-85.