Infective Endocarditis After TAVR

INfecTive ENdocarditis After Transcatheter Aortic Valve Replacement (TAVR) a National SwEdish Study (INTENSE)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03768180

Acronym

INTENSE

Enrollment

4600

Registered

2018-12-07

Start date

2018-01-01

Completion date

2019-08-01

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Endocarditis of Aortic Valve

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Infective Endocarditis	5 year	Patients that have suffered an infective endocarditis will be described, where survival is one important variable

Countries

Sweden

Outcome results