Re-hospitalisation After Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

— HOSPITAVI  

Official title:

Re-hospitalisation After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670041
• Other study ID #: H-21036155
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: March 16, 2025

Study information

• Verified date: September 2023
• Source: Rigshospitalet, Denmark
• Contact: Pernille Steen Bække, MD
• Phone: 35457214
• Email: pernille.steen.baekke.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 16, 2025
• Est. primary completion date: March 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis

Intervention

Behavioral:
• Intensified follow-up
Early, intensified follow-up after discharge from TAVI-procedure.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Ole De Backer

Country where clinical trial is conducted

Denmark, 

Outcome

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