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Re-hospitalisation After Transcatheter Aortic Valve Implantation (HOSPITAVI)

Primary Purpose

Aortic Valve Disease, Aortic Valve Stenosis

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Intensified follow-up

About this trial

This is an interventional supportive care trial for Aortic Valve Disease focused on measuring Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard follow-up

Intensified follow-up

Arm Description

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

Outcomes

Primary Outcome Measures

The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI

Primary safety endpoint

Quality-of-life adjusted life years at 90 days after the TAVI-procedure

Primary efficacy endpoint

Secondary Outcome Measures

The risk of all-cause mortality

Full Information

NCT ID

NCT05670041

First Posted

January 2, 2023

Last Updated

September 4, 2023

Sponsor

Ole De Backer

1. Study Identification

Unique Protocol Identification Number

NCT05670041

Brief Title

Re-hospitalisation After Transcatheter Aortic Valve Implantation

Acronym

HOSPITAVI

Official Title

Re-hospitalisation After Transcatheter Aortic Valve Implantation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 16, 2023 (Actual)

Primary Completion Date

March 16, 2024 (Anticipated)

Study Completion Date

March 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ole De Backer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Disease, Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard follow-up

Arm Type

No Intervention

Arm Title

Intensified follow-up

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Intensified follow-up

Intervention Description

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

Primary Outcome Measure Information:

Title

The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI

Description

Primary safety endpoint

Time Frame

365 days

Title

Quality-of-life adjusted life years at 90 days after the TAVI-procedure

Description

Primary efficacy endpoint

Time Frame

365 days

Secondary Outcome Measure Information:

Title

The risk of all-cause mortality

Time Frame

365 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pernille Steen Bække, MD

Phone

35457214

pernille.steen.baekke.02@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Lars Sondergaard, Professor

Phone

35458693

lars.soendergaard.01@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Sondergaard, Professor

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ole De Backer

ole.debacker@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Re-hospitalisation After Transcatheter Aortic Valve Implantation

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