Swedish Study on STroke After TAVR

Stroke Clinical Trial

— SWESTAT  

Official title:

Swedish Study on STroke After TAVR. A Nationwide All-comers Study of the Risk of Stroke After Transcatheter Aortic Valve Replacemant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086836
• Other study ID #: SWESTAT
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: April 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims at studying the frequency of late stroke after transcatheter aortic valve replacement/implantation

Description:

Since the start of transcatheter aortic valve implnatations/replacements (TAVR/TAVI) implantations in Sweden in 2008 all procedures have been added to a national database, which now contains 5000+ procedures. At the same time, all admissions to the hospital is also recorded with diagnosis in a separate database. We intend to make a nation-wide complete follow up of all TAVR/TAVI patients in swede that has received the diagnosis of stroke after the implantation. In addition data will also be collected from the national stroke database for detailed information of the cases

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4600
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All patients that has under TAVR/TAVI in Sweden between 2008 and 2018 Exclusion Criteria:

Patients unable to follow up due to emigration or missing social security number

Exclusion Criteria:

Periprocedural stroke

Related Conditions & MeSH terms

• Aortic Valve Disease
• Stroke

Intervention

Device:
• TAVR
Patient recieving a TAVR

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke	Stroke as defined by the national stroke database	5 year