HOSPITAVI: Re-hospitalisation After Transcatheter Aortic Valve Implantation
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 |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention: Standard follow-up
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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.
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Outcome Measures
Primary Outcome Measures
- The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI [365 days]
Primary safety endpoint
- Quality-of-life adjusted life years at 90 days after the TAVI-procedure [365 days]
Primary efficacy endpoint
Secondary Outcome Measures
- The risk of all-cause mortality [365 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who underwent technical successful TAVI
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Residing in Denmark
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Provided written informed consent
Exclusion Criteria:
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Index admission mortality
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Index admission conversion to open surgery
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Age < 18 years
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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.- H-21036155