Re-hospitalisation After Transcatheter Aortic Valve Implantation
HOSPITAVI
1 other identifier
interventional
500
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 4, 2023
CompletedStudy Start
First participant enrolled
January 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2025
CompletedSeptember 7, 2023
September 1, 2023
1.2 years
January 2, 2023
September 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI
Primary safety endpoint
365 days
Quality-of-life adjusted life years at 90 days after the TAVI-procedure
Primary efficacy endpoint
365 days
Secondary Outcomes (1)
The risk of all-cause mortality
365 days
Study Arms (2)
Standard follow-up
NO INTERVENTIONIntensified follow-up
EXPERIMENTALEarly, intensified follow-up after discharge from TAVI-procedure consisting of telephone consults and an additional visit to the outpaitent clinic.
Interventions
Early, intensified follow-up after discharge from TAVI-procedure.
Eligibility Criteria
You may qualify if:
- Patients who underwent technical successful TAVI
- Residing in Denmark
- Provided written informed consent
You may not qualify if:
- Index admission mortality
- Index admission conversion to open surgery
- Age \< 18 years
- Women of childbearing potential, pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ole De Backerlead
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 39900323DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Sondergaard, Professor
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, dr. med.
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 4, 2023
Study Start
January 16, 2023
Primary Completion
March 16, 2024
Study Completion
March 16, 2025
Last Updated
September 7, 2023
Record last verified: 2023-09