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Infective Endocarditis After TAVR (INTENSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03768180
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Region Skane

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

Condition or disease
Infective Endocarditis of Aortic Valve

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.

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Study Type : Observational
Actual Enrollment : 4600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: INfecTive ENdocarditis After Transcatheter Aortic Valve Replacement (TAVR) a National SwEdish Study (INTENSE)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Group/Cohort
Patient with infective endocarditis
All patients diagnosed with infective endocarditis after TAVR



Primary Outcome Measures :
  1. Infective Endocarditis [ Time Frame: 5 year ]
    Patients that have suffered an infective endocarditis will be described, where survival is one important variable



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients that has under TAVR/TAVI in Sweden between 2008 and 2018
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768180


Locations
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Sweden
Skane University Hospital
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03768180     History of Changes
Other Study ID Numbers: IETAVR
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection