Re-hospitalisation After Transcatheter Aortic Valve Implantation

NCT ID: NCT05670041

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2025-03-16

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Disease Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Intensified follow-up

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

Group Type EXPERIMENTAL

Intensified follow-up

Intervention Type BEHAVIORAL

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

Interventions

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Intensified follow-up

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ole De Backer

OTHER

Sponsor Role lead

Responsible Party

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Ole De Backer

Professor, dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lars Sondergaard, Professor

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Pernille Steen Bække, MD

Role: CONTACT

Lars Sondergaard, Professor

Role: CONTACT

Facility Contacts

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Ole De Backer

Role: primary

References

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Baekke PS, Jorgensen TH, Bieliauskas G, Sondergaard L, De Backer O. Impact of Intensified Outpatient Follow-Up on Rehospitalization After Transcatheter Aortic Valve Implantation: Results From the HOSPITAVI Trial. Am J Cardiol. 2025 Jun 15;245:17-24. doi: 10.1016/j.amjcard.2025.01.031. Epub 2025 Feb 1.

Reference Type DERIVED
PMID: 39900323 (View on PubMed)

Other Identifiers

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H-21036155

Identifier Type: -

Identifier Source: org_study_id

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