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Re-hospitalisation After Transcatheter Aortic Valve Implantation

NCT05670041 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-09-07

No results posted yet for this study

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.

Conditions

  • Aortic Valve Disease
  • Aortic Valve Stenosis

Interventions

BEHAVIORAL

Intensified follow-up

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

Sponsors & Collaborators

  • Ole De Backer

    lead OTHER

Principal Investigators

  • Lars Sondergaard, Professor · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2024-03-16
Completion
2025-03-16

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670041 on ClinicalTrials.gov