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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01119716
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Study Start: 2010-05-25
• Primary Completion: 2013-02-15
• Study Completion: 2013-02-15
• Results First Submitted: 2013-12-13
• Results First Submitted QC: 2013-12-13
• Results First Posted: 2014-01-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4658

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Type of Atrial Fibrillation at Baseline (Admission)	Baseline (time of admission)
Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion	At time of treatment (up to 1 day from admission)	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.
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)	Baseline (time of admission)
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation	up to 60 days from day of treatment (cardioversion)
Treatments Utilized for Participants for Atrial Fibrillation	At time of Treatment (up to 1 day from admission)
Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)	Baseline (time of admission)