Infective Endocarditis After TAVR

Infective Endocarditis of Aortic Valve Clinical Trial

— INTENSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768180
• Other study ID #: IETAVR
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims at studying the frequency of infective endocarditis after transcatheter aortic valve replacement/implantation

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4600
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis of Aortic Valve

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

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