Infective Endocarditis After TAVR | NCT03768180

Studies
Infective Endocarditis After TAVR

NCT03768180

Sponsor

Region Skane

Status

Completed

Last Update Posted

Apr 6, 2020Actual

Enrollment

4,600Actual

Phase

Not provided

Conditions

Infective Endocarditis of Aortic Valve

Interventions

Not provided

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

Mar 2019

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

Jan 1, 2018Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Dec 6, 2018

First Submission Date that Met QC Criteria

Dec 6, 2018

First Posted Date

Dec 7, 2018Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims at studying the frequency of infective endocarditis 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 4500+ 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 infective endocarditis after the implantation. In addition data will also be collected from the national endocarditis 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

Target Follow-Up Duration

Not provided

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 with infective endocarditis		All patients diagnosed with infective endocarditis after TAVR

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infective Endocarditis	Patients that have suffered an infective endocarditis will be described, where survival is one important variable	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

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 patients that has under TAVR/TAVI in Sweden between 2008 and 2018

Sampling Method

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31433472	Derived	Bjursten H, Rasmussen M, Nozohoor S, Gotberg M, Olaison L, Ruck A, Ragnarsson S. Infective endocarditis after transcatheter aortic valve implantation: a nationwide study. Eur Heart J. 2019 Oct 14;40(39):3263-3269. doi: 10.1093/eurheartj/ehz588.