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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
ClinicalTrials.gov Identifier:
NCT01119716
First received: May 6, 2010
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Registry on Cardioversion of Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]
  • Treatment patterns for the cardioversion of patients with acute symptomatic atrial fibrillation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Success rate of different cardioversion procedures [ Time Frame: 1 Day ] [ 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: No ]

Enrollment: 4899
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Afib
Patients presenting with atrial fibrillation planned to undergo cardioversion treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Patient with documented atrial fibrillation (confirmed by ECG) in the hospital setting at the time of enrollment
  • Planned cardioversion (of AF)

Exclusion Criteria:

  • Already enrolled in this or any other clinical trial
  • Atrial flutter
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119716

Sponsors and Collaborators
Merck
Institut für Herzinfarktforschung an der Universität Heidelberg
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01119716     History of Changes
Other Study ID Numbers: 6621-051, 2010_025
Study First Received: May 6, 2010
Last Updated: March 14, 2013
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Merck:
Atrial Fibrillation
Afib
cardioversion
 normal sinus rhythm
arrhythmia
AF

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013