Trials / Not Yet Recruiting
Not Yet RecruitingNCT06953206
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Institut für Pharmakologie und Präventive Medizin · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Detailed description
Transcatheter aortic valve replacement (TAVI) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomized trials including low risk patients, this treatment has been progressively applied to younger (in the sixties and seventies) patients with a low co-morbidity burden. Life expectancy in this group is expected to extend beyond 5 years from intervention in the vast majority of patients, and beyond 10 years in a high proportion. Thus, the issue of valve durability has become one of the most important aspects in the TAVI field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVI have been consistently \<10%, but some studies have shown some degree of valve structural degeneration in close to one third of the patients at 8-year follow-up. This subclinical valve degeneration before the 10-year follow-up landmark would represent the initial step in the process of bioprosthetic valve failure, and further valve degeneration leading to clinical symptoms is likely to occur in a significant proportion of these cases. This prospective registry will evaluate the clinical outcomes and the valve performance of the SAPIEN 3 Ultra RESILIA valve over 10 years.
Conditions
- Transcatheter Aortic Valve Replacement (TAVR)
- Aortic-Stenosis
- Aortic Insufficiency
- Degenerative Valve Disease
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transcatheter aortic valve (S3UR) replacement (TAVR) | Elective transfemoral TAVi procedure with S3UR valve. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2037-05-30
- Completion
- 2037-09-30
- First posted
- 2025-05-01
- Last updated
- 2026-03-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06953206. Inclusion in this directory is not an endorsement.