Re-hospitalisation After Transcatheter Aortic Valve Implantation (HOSPITAVI)

Ole De Backer

Status: Enrolling

Conditions: Aortic Valve Stenosis; Aortic Valve Disease

Treatments: Behavioral: Intensified follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT05670041

H-21036155

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Standard follow-up

No Intervention group

Intensified follow-up

Experimental group

Description:

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

Treatment:

Behavioral: Intensified follow-up