HOSPITAVI: Re-hospitalisation After Transcatheter Aortic Valve Implantation

• Sponsor: Lars Soendergaard (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05670041
• Collaborator: (none)
• Enrollment: 500
• Arms: 2
• Anticipated Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease; Aortic Valve Stenosis	Behavioral: Intensified follow-up	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Re-hospitalisation After Transcatheter Aortic Valve Implantation
• Anticipated Study Start Date: Jan 16, 2023
• Anticipated Primary Completion Date: Mar 16, 2024
• Anticipated Study Completion Date: Mar 16, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard follow-up
Experimental: Intensified follow-up Early, intensified follow-up after discharge from TAVI-procedure consisting of telephone consults and an additional visit to the outpaitent clinic.	Behavioral: Intensified follow-up; Early, intensified follow-up after discharge from TAVI-procedure.

Outcome Measures

Primary Outcome Measures

1. The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI [365 days]

   Primary safety endpoint

2. Quality-of-life adjusted life years at 90 days after the TAVI-procedure [365 days]

   Primary efficacy endpoint

Secondary Outcome Measures

1. The risk of all-cause mortality [365 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Lars Soendergaard

Investigators

• Principal Investigator: Lars Sondergaard, Professor, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lars Soendergaard, Professor, dr. med., Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT05670041
• Other Study ID Numbers: H-21036155
• First Posted: Jan 4, 2023
• Last Update Posted: Jan 4, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lars Soendergaard, Professor, dr. med., Rigshospitalet, Denmark: Transcatheter Aortic Valve Implantation; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis
• Additional relevant MeSH terms: Aortic Valve Stenosis; Aortic Valve Disease

Study Results

No Results Posted as of Jan 4, 2023