Re-hospitalisation After Transcatheter Aortic Valve Implantation

Not Applicable

Recruiting

• Conditions: Aortic Valve Disease; Aortic Valve Stenosis
• Interventions: Behavioral: Intensified follow-up

• Registration Number: NCT05670041
• Lead Sponsor: Ole De Backer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-02
• Study First Posted: 2023-01-04
• Study Start: 2023-01-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-03-16
• Study Completion: 2025-03-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intensified follow-up	Intensified follow-up	Early, intensified follow-up after discharge from TAVI-procedure consisting of telephone consults and an additional visit to the outpaitent clinic.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The risk of all-cause mortality	365 days

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark