Re-hospitalisation After Transcatheter Aortic Valve Implantation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05670041

Acronym

HOSPITAVI

Enrollment

500

Registered

2023-01-04

Start date

2023-01-16

Completion date

2025-03-16

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis

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.

Interventions

BEHAVIORALIntensified follow-up

Early, intensified follow-up after discharge from TAVI-procedure.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who underwent technical successful TAVI * Residing in Denmark * Provided written informed consent

Exclusion criteria

* Index admission mortality * Index admission conversion to open surgery * Age \< 18 years * Women of childbearing potential, pregnant or nursing

Design outcomes

Primary

Measure	Time frame	Description
The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI	365 days	Primary safety endpoint
Quality-of-life adjusted life years at 90 days after the TAVI-procedure	365 days	Primary efficacy endpoint

Secondary

Measure	Time frame
The risk of all-cause mortality	365 days

Countries

Denmark

Contacts

Primary ContactPernille Steen Bække, MD

pernille.steen.baekke.02@regionh.dk35457214

Backup ContactLars Sondergaard, Professor

lars.soendergaard.01@regionh.dk35458693

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026