Aortic Valve DiseaseHOSPITAVINCT05670041
Re-hospitalisation After Transcatheter Aortic Valve Implantation
A study testing Intensified follow-up in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Ole De Backer at 1 site in Denmark.
Trial summary
The goal of this study is to investigate whether patient-tailored follow-up for patients treated with transcatheter aortic valve implantation (TAVI) can prevent re-hospitalisation and improve quality of life compared with the standard follow-up program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis
- What is being tested?
- Intensified follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jan 2023to 16 Mar 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent technical successful TAVI
- Residing in Denmark
- Provided written informed consent
Who cannot join
- Index admission mortality
- Index admission conversion to open surgery
- Age < 18 years
- Women of childbearing potential, pregnant or nursing
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Ole De Backer, ole.debacker@gmail.com
About this study
The goal of this study is to investigate whether patient-tailored follow-up for patients treated with transcatheter aortic valve implantation (TAVI) can prevent re-hospitalisation and improve quality of life compared with the standard follow-up program.
The rationale of this study is the persistently high rate of re-hospitalisation after TAVI, which increases the risk of mortality and diminishes the patient-evaluated quality of life. Our hypothesis is that patient-tailored follow-up for patients treated with TAVI will reduce the rate of re-hospitalisation after the TAVI-procedure and improve quality of life.
The primary endpoints are the rate of re-hospitalisation within 90 days of the procedure and quality of life adjusted life years at 90-day follow-up.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Being tested
- Intensified follow-up
- Keywords
- Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified follow-upBehavioural
Early, intensified follow-up after discharge from TAVI-procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard follow-up | No intervention | Not described |
| Intensified follow-up | Experimental | Early, intensified follow-up after discharge from TAVI-procedure consisting of telephone consults and an additional visit to the outpaitent clinic. Receives: Behavioral: Intensified follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI
Primary safety endpoint
Measured: 365 days
Quality-of-life adjusted life years at 90 days after the TAVI-procedure
Primary efficacy endpoint
Measured: 365 days
Secondary outcomes (1)
The risk of all-cause mortality
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start16 Jan 2023
- Primary completion16 Mar 2024 (estimated)
- Study completion16 Mar 2025 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ole De Backer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole De Backer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Sondergaard, Professor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670041
- Sponsor's protocol ID
- H-21036155
- Acronym
- HOSPITAVI
- Status last verified
- Sep 2023
- First submitted
- 2 Jan 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baekke PS, Jorgensen TH, Bieliauskas G, Sondergaard L, De Backer O. Impact of Intensified Outpatient Follow-Up on Rehospitalization After Transcatheter Aortic Valve Implantation: Results From the HOSPITAVI Trial. Am J Cardiol. 2025 Jun 15;245:17-24. doi: 10.1016/j.amjcard.2025.01.031. Epub 2025 Feb 1.
PubMed 39900323
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-hospitalisation After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05670041
- Acronym / sponsor ID
- HOSPITAVI / H-21036155
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ole De BackerUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 16 Mar 2024 (estimated)
- Study completion
- 16 Mar 2025 (estimated)
- First posted
- 4 Jan 2023 (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.
The goal of this study is to investigate whether patient-tailored follow-up for patients treated with transcatheter aortic valve implantation (TAVI) can prevent re-hospitalisation and improve quality of life compared with the standard follow-up program.
The rationale of this study is the persistently high rate of re-hospitalisation after TAVI, which increases the risk of mortality and diminishes the patient-evaluated quality of life. Our hypothesis is that patient-tailored follow-up for patients treated with TAVI will reduce the rate of re-hospitalisation after the TAVI-procedure and improve quality of life.
The primary endpoints are the rate of re-hospitalisation within 90 days of the procedure and quality of life adjusted life years at 90-day follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard follow-up | No intervention | – |
| Intensified follow-up | Experimental | Behavioral: Intensified follow-upEarly, intensified follow-up after discharge from TAVI-procedure consisting of telephone consults and an additional visit to the outpaitent clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent technical successful TAVI
- Residing in Denmark
- Provided written informed consent
Key exclusion criteria (4 listed)
- Index admission mortality
- Index admission conversion to open surgery
- Age < 18 years
- Women of childbearing potential, pregnant or nursing
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 |
|---|---|---|
| Intensified follow-upEarly, intensified follow-up after discharge from TAVI-procedure. | Behavioural | Intensified follow-up |
Primary outcome
The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI
Time frame: 365 days
Primary safety endpoint
Quality-of-life adjusted life years at 90 days after the TAVI-procedure
Time frame: 365 days
Primary efficacy endpoint
1 secondary outcome
The risk of all-cause mortality
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 39900323Baekke PS, Jorgensen TH, Bieliauskas G, Sondergaard L, De Backer O. Impact of Intensified Outpatient Follow-Up on Rehospitalization After Transcatheter Aortic Valve Implantation: Results From the HOSPITAVI Trial. Am J Cardiol. 2025 Jun 15;245:17-24. doi: 10.1016/j.amjcard.2025.01.031. Epub 2025 Feb 1.
- Individual participant dataSharing planned: Undecided
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Lars Sondergaard, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified follow-up in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Ole De Backer at 1 site in Denmark.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pernille Steen Bække, MD (35457214, pernille.steen.baekke.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI (time frame: 365 days). The study lists 2 primary outcomes in all. 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 NCT05670041, 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 7 Sep 2023.