Tailored follow-up to reduce hospital readmissions after heart valve surgery
Re-hospitalisation After Transcatheter Aortic Valve Implantation
This study tests if a personalized follow-up plan can help people who had heart valve surgery stay out of the hospital and feel better compared to regular follow-up care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05670041 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a personalized follow-up program for patients who have undergone transcatheter aortic valve implantation (TAVI) can reduce the rate of re-hospitalization and enhance quality of life compared to standard follow-up. The study addresses the high re-hospitalization rates that can lead to increased mortality and decreased quality of life for these patients. The primary endpoints include the rate of re-hospitalization within 90 days post-procedure and the assessment of quality of life adjusted life years at the same follow-up period.
Who should consider this trial
Good fit: Ideal candidates are patients who have successfully undergone TAVI and reside in Denmark.
Not a fit: Patients who experienced mortality during the initial admission or required conversion to open surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital readmissions and improve the quality of life for patients after TAVI.
How similar studies have performed: While the approach of tailored follow-up is innovative, similar studies have shown promise in improving outcomes in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Lars Sondergaard, Professor — Rigshospitalet, Denmark
- Study coordinator: Pernille Steen Bække, MD
- Email: pernille.steen.baekke.02@regionh.dk
- Phone: 35457214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.