Swedish Study on STroke After TAVR

Completed

• Conditions: Stroke; Aortic Valve Disease
• Interventions: Device: TAVR

• Registration Number: NCT04086836
• Lead Sponsor: Region Skane

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient suffering a late stroke after TAVR	TAVR	All patients suffering a stroke after TAVR will be studied

Primary Outcome Measures

Name	Time	Method
Stroke	5 year	Stroke as defined by the national stroke database

Trial Locations

Locations (1)

Skane University Hospital; 🇸🇪 Lund, Sweden