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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
500
Early, intensified follow-up after discharge from TAVI-procedure.
Rigshospitalet
Copenhagen, Denmark
RECRUITINGThe rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI
Primary safety endpoint
Time frame: 365 days
Quality-of-life adjusted life years at 90 days after the TAVI-procedure
Primary efficacy endpoint
Time frame: 365 days
The risk of all-cause mortality
Time frame: 365 days
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