International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051) (RHYTHM-AF)

This study has been completed.
Sponsor:
Collaborator:
Institut für Herzinfarktforschung an der Universität Heidelberg
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01119716
First received: May 6, 2010
Last updated: March 24, 2014
Last verified: March 2014

May 6, 2010
March 24, 2014
May 2010
February 2013   (final data collection date for primary outcome measure)
  • Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission) [ Time Frame: Baseline (time of admission) ] [ Designated as safety issue: No ]
  • Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission) [ Time Frame: Baseline (time of admission) ] [ Designated as safety issue: No ]
  • Clinical Type of Atrial Fibrillation at Baseline (Admission) [ Time Frame: Baseline (time of admission) ] [ Designated as safety issue: No ]
  • Treatments Utilized for Participants for Atrial Fibrillation [ Time Frame: At time of Treatment (up to 1 day from admission) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion [ Time Frame: At time of treatment (up to 1 day from admission) ] [ Designated as safety issue: No ]
    Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.
  • Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation [ Time Frame: up to 60 days from day of treatment (cardioversion) ] [ Designated as safety issue: No ]
  • Treatment patterns for the cardioversion of patients with acute symptomatic atrial fibrillation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Characteristics of patients presenting with atrial fibrillation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Prevalence of different kinds of atrial fibrillation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Incidence of recurrence of atrial fibrillation, death, myocardial infarction, stroke, peripheral embolisms, and bleeding complications [ Time Frame: Through 60 Days ] [ Designated as safety issue: Yes ]
  • Success rate of different cardioversion procedures [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01119716 on ClinicalTrials.gov Archive Site
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International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
International Registry on Cardioversion of Atrial Fibrillation

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Atrial Fibrillation
Not Provided
All Enrolled Participants
Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, Lewalter T, Lip GY, Maggioni AP, Martín 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4658
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01119716
6621-051, 2010_025
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Institut für Herzinfarktforschung an der Universität Heidelberg
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP