NCT04086836

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

September 10, 2019

Last Update Submit

April 3, 2020

Conditions

Aortic Valve DiseaseStroke

Keywords

TAVRStroke

Outcome Measures

Primary Outcomes (1)

  • Stroke

    Stroke as defined by the national stroke database

    5 year

Study Arms (1)

Patient suffering a late stroke after TAVR

All patients suffering a stroke after TAVR will be studied

Device: TAVR

Interventions

TAVRDEVICE

Patient recieving a TAVR

Patient suffering a late stroke after TAVR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All pateints recieving a TAVR device in Sweden during study period

You may not qualify if:

  • Periprocedural stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skane University Hospital

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Aortic Valve DiseaseStroke

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 12, 2019

Study Start

July 1, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)