Swedish Study on STroke After TAVR | NCT04086836

Studies
Swedish Study on STroke After TAVR

NCT04086836

Sponsor

Region Skane

Status

Completed

Last Update Posted

Apr 6, 2020Actual

Enrollment

4,600Actual

Phase

Not provided

Conditions

Aortic Valve Disease
Stroke

Interventions

TAVR

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Feb 1, 2020Actual

First Submitted Date

Sep 10, 2019

First Submission Date that Met QC Criteria

Sep 10, 2019

First Posted Date

Sep 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2020

Last Update Posted Date

Apr 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient suffering a late stroke after TAVR		All patients suffering a stroke after TAVR will be studied	Device: TAVR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAVR	Device	Patient recieving a TAVR	Patient suffering a late stroke after TAVR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke	Stroke as defined by the national stroke database	5 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All pateints recieving a TAVR device in Sweden during study period

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skane University Hospital		Lund		22185	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Submission Tracking

Estimated Results First Submitted Date

Oct 25, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 25, 2022			Nov 17, 2022	3
Nov 16, 2023

Condition Browse Module

MeSH Terms

ID	Term
D000082862	Aortic Valve Disease
D020521	Stroke

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D002561	Cerebrovascular Disorders

Browse Leaves

Not provided

Browse Branches

Not provided