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

Atrial Fibrillation Clinical Trial

— RHYTHM-AF  

Official title:

International Registry on Cardioversion of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119716
• Other study ID #: 6621-051
• Secondary ID: 2010_025
• Status: Completed
• Start date: May 25, 2010
• Est. completion date: February 15, 2013

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4658
• Est. completion date: February 15, 2013
• Est. primary completion date: February 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC	Institut für Herzinfarktforschung an der Universität Heidelberg

References & Publications (1)

Crijns HJ, Weijs B, Fairley AM, Lewalter T, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bash LD, Chazelle F, Bernhardt A, Gitt AK, Lip GY, Le Heuzey JY. Contemporary real life cardioversion of atrial fibrillation: Results f — View Citation

Outcome

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