Aortic Valve DiseaseSWESTATNCT04086836
Swedish Study on STroke After TAVR
An observational study of Aortic Valve Disease and Stroke, run by Region Skane at 1 site in Sweden.
Trial summary
This study aims at studying the frequency of late stroke after transcatheter aortic valve replacement/implantation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease, Stroke
- What is being tested?
- TAVR
- Type of treatment
- Medical device
- How many people
- 4,600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2019to 1 Feb 2020
- How long will I take part?
- 10 Years
- 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 pateints recieving a TAVR device in Sweden during study period
Who may be able to join
- 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
Who cannot join
- Periprocedural stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swedish Study on STroke After TAVR. A Nationwide All-comers Study of the Risk of Stroke After Transcatheter Aortic Valve Replacemant
This study aims at studying the frequency of late stroke 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 5000+ 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 stroke after the implantation. In addition data will also be collected from the national stroke database for detailed information of the cases
- Conditions
- Aortic Valve Disease, Stroke
- Being tested
- TAVR
- Keywords
- TAVR, Stroke
- Medical subject headings
- Aortic Valve Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVRDevice
Patient recieving a TAVR
| Study group | Role | What they receive |
|---|---|---|
| Patient suffering a late stroke after TAVR | All patients suffering a stroke after TAVR will be studied Receives: Device: TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
Stroke as defined by the national stroke database
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 posted12 Sep 2019
- Study start1 Jul 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Prospective
- Enrolment
- 4,600 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086836
- Sponsor's protocol ID
- SWESTAT
- Acronym
- SWESTAT
- Status last verified
- Apr 2020
- First submitted
- 10 Sep 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Swedish Study on STroke After TAVR. A Nationwide All-comers Study of the Risk of Stroke After Transcatheter Aortic Valve Replacemant
- ClinicalTrials.gov ID
- NCT04086836
- Acronym / sponsor ID
- SWESTAT / SWESTAT
- Conditions
- Aortic Valve Disease, Stroke
- Keywords
- TAVR, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,600 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 12 Sep 2019 (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 late stroke 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 5000+ 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 stroke after the implantation. In addition data will also be collected from the national stroke database for detailed information of the cases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient suffering a late stroke after TAVR | – | Device: TAVRAll patients suffering a stroke after TAVR will be studied |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pateints recieving a TAVR device in Sweden during study period
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Periprocedural stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVRPatient recieving a TAVR | Device | Patient suffering a late stroke after TAVR |
Primary outcome
Stroke
Time frame: 5 year
Stroke as defined by the national stroke database
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.
- 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 Aortic Valve Disease and Stroke, 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?
Stroke (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.