Infective Endocarditis of Aortic ValveINTENSENCT03768180
Infective Endocarditis After TAVR
An observational study of Infective Endocarditis of Aortic Valve, run by Region Skane at 1 site in Sweden.
Trial summary
This study aims at studying the frequency of infective endocarditis after transcatheter aortic valve replacement/implantation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infective Endocarditis of Aortic Valve
- How many people
- 4,600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that has under TAVR/TAVI in Sweden between 2008 and 2018
Who may be able to join
- All patients that has under TAVR/TAVI in Sweden between 2008 and 2018
Who cannot join
- Patients unable to follow up due to emigration or missing social security number
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INfecTive ENdocarditis After Transcatheter Aortic Valve Replacement (TAVR) a National SwEdish Study (INTENSE)
This study aims at studying the frequency of infective endocarditis after transcatheter aortic valve replacement/implantation
Read the 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.
- Conditions
- Infective Endocarditis of Aortic Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with infective endocarditis | All patients diagnosed with infective endocarditis after TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infective Endocarditis
Patients that have suffered an infective endocarditis will be described, where survival is one important variable
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Jan 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infective Endocarditis of Aortic ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768180
- Sponsor's protocol ID
- IETAVR
- Acronym
- INTENSE
- Status last verified
- Mar 2019
- First submitted
- 6 Dec 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31433472
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INfecTive ENdocarditis After Transcatheter Aortic Valve Replacement (TAVR) a National SwEdish Study (INTENSE)
- ClinicalTrials.gov ID
- NCT03768180
- Acronym / sponsor ID
- INTENSE / IETAVR
- Conditions
- Infective Endocarditis of Aortic Valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,600 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with infective endocarditis | – | –All patients diagnosed with infective endocarditis after TAVR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that has under TAVR/TAVI in Sweden between 2008 and 2018
Key inclusion criteria (1 listed)
- All patients that has under TAVR/TAVI in Sweden between 2008 and 2018
Key exclusion criteria (1 listed)
- Patients unable to follow up due to emigration or missing social security number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infective Endocarditis
Time frame: 5 year
Patients that have suffered an infective endocarditis will be described, where survival is one important variable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Derived from this study: PubMed 31433472Bjursten 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis of Aortic Valve, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infective Endocarditis (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.