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

NCT ID: NCT01119716

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4658 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-25
• Study Completion Date: 2013-02-15

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Enrolled Participants

Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut für Herzinfarktforschung an der Universität Heidelberg

UNKNOWN

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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 from the multinational RHYTHM-AF study. Int J Cardiol. 2014 Apr 1;172(3):588-94. doi: 10.1016/j.ijcard.2014.01.099. Epub 2014 Jan 25.

Reference Type: RESULT

PMID: 24556445 (View on PubMed)

Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, Lewalter T, Lip GY, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bernhardt AA, Unniachan S, Phatak HM, Gitt AK. RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers. BMC Cardiovasc Disord. 2012 Oct 2;12:85. doi: 10.1186/1471-2261-12-85.

Reference Type: DERIVED

PMID: 23031215 (View on PubMed)

Other Identifiers

2010_025

Identifier Type: -

Identifier Source: secondary_id

6621-051

Identifier Type: -

Identifier Source: org_study_id