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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard follow-up | No Intervention | ||
| Intensified follow-up | Experimental | Early, intensified follow-up after discharge from TAVI-procedure consisting of telephone consults and an additional visit to the outpaitent clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensified follow-up | Behavioral | Early, intensified follow-up after discharge from TAVI-procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of all-cause hospitalisations between discharge from the index procedure and 90 days post-TAVI | Primary safety endpoint | 365 days |
| Quality-of-life adjusted life years at 90 days after the TAVI-procedure | Primary efficacy endpoint | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| The risk of all-cause mortality | 365 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pernille Steen Bække, MD | Contact | 35457214 | pernille.steen.baekke.02@regionh.dk | |
| Lars Sondergaard, Professor | Contact | 35458693 | lars.soendergaard.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lars Sondergaard, Professor | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39900323 | Derived | 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. |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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