Re-hospitalisation After Transcatheter Aortic Valve Implantation
NCT ID: NCT05670041
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2023-01-16
2025-03-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Standard follow-up
No interventions assigned to this group
Intensified follow-up
Early, intensified follow-up after discharge from TAVI-procedure consisting of telephone consults and an additional visit to the outpaitent clinic.
Intensified follow-up
Early, intensified follow-up after discharge from TAVI-procedure.
Interventions
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Intensified follow-up
Early, intensified follow-up after discharge from TAVI-procedure.
Eligibility Criteria
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Inclusion Criteria
* Residing in Denmark
* Provided written informed consent
Exclusion Criteria
* Index admission conversion to open surgery
* Age \< 18 years
* Women of childbearing potential, pregnant or nursing
18 Years
ALL
No
Sponsors
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Ole De Backer
OTHER
Responsible Party
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Ole De Backer
Professor, dr. med.
Principal Investigators
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Lars Sondergaard, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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H-21036155
Identifier Type: -
Identifier Source: org_study_id
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