Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation

Stroke Clinical Trial

— CAREAVR  

Official title:

Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626871
• Other study ID #: T39/2015
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: May 1, 2017
• Start date: January 2002
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• patients undergoing aortic valve bioprosthesis implantation

Exclusion Criteria:

• mechanical heart valves in any position

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Atrial Fibrillation
• Bleeding
• Hemorrhage
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (4)

Lead Sponsor	Collaborator
University of Turku	Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke		10 years
Primary	Mortality		10 years
Primary	atrial fibrillation		10 years
Primary	major bleeding		10 years