Non-vitamin K Oral Anticoagulants in Cardioversion

Atrial Fibrillation Clinical Trial

— FinCV3  

Official title:

Non-vitamin K Oral Anticoagulants in Cardioversion of Atrial Fibrillation. FinCV3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911545
• Other study ID #: FinCV3
• Status: Completed
• Phase: N/A
• First received: September 16, 2016
• Last updated: September 21, 2016
• Start date: October 2011
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Terveyden ja Hyvinvoinnin laitos, National Institute for Health and Welfare
• Study type: Observational

Clinical Trial Summary

Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. The aim of this study is to investigate the complications and the use of NOACs in AF patients undergoing cardioversion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• AF patients undergoing cardioversion

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Turku

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and predictors of thromboembolic complications		31 days after cardioversion of persistent AF	Yes
Primary	Incidence and predictors of bleeding		31 days after cardioversion of persistent AF	Yes
Secondary	Number of recurrence of AF		31 days after cardioversion of persistent AF	Yes
Secondary	Hemodynamic complications of cardioversion		31 days after cardioversion of persistent AF	Yes