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
Results First Received: December 13, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Atrial Fibrillation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Enrolled Participants Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

Participant Flow:   Overall Study
    All Enrolled Participants  
STARTED     4658  
COMPLETED     4658  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Enrolled Participants Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

Baseline Measures
    All Enrolled Participants  
Number of Participants  
[units: participants]
  4658  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 12.5  
Gender  
[units: Participants]
 
Female     1742  
Male     2916  



  Outcome Measures
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1.  Primary:   Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)   [ Time Frame: Baseline (time of admission) ]

2.  Primary:   Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)   [ Time Frame: Baseline (time of admission) ]

3.  Primary:   Clinical Type of Atrial Fibrillation at Baseline (Admission)   [ Time Frame: Baseline (time of admission) ]

4.  Primary:   Treatments Utilized for Participants for Atrial Fibrillation   [ Time Frame: At time of Treatment (up to 1 day from admission) ]

5.  Primary:   Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion   [ Time Frame: At time of treatment (up to 1 day from admission) ]

6.  Primary:   Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation   [ Time Frame: up to 60 days from day of treatment (cardioversion) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01119716     History of Changes
Other Study ID Numbers: 6621-051, 2010_025
Study First Received: May 6, 2010
Results First Received: December 13, 2013
Last Updated: March 24, 2014
Health Authority: Spain: Spanish Drug Agency