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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01119716
First received: May 6, 2010
Last updated: October 1, 2014
Last verified: October 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 4658
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
All Enrolled Participants
Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

  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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119716

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Institut für Herzinfarktforschung an der Universität Heidelberg
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 1, 2014
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Atrial Fibrillation
Afib
cardioversion
normal sinus rhythm
arrhythmia
AF

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

ClinicalTrials.gov processed this record on November 25, 2014