Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter aortic valve (S3UR) replacement (TAVR).
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry
Overview
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.
Interventions
- Procedure Transcatheter aortic valve (S3UR) replacement (TAVR)
Elective transfemoral TAVi procedure with S3UR valve.
Primary outcome measures
- Early Safety [Time frame: 1-3 months]
- Device Success [Time frame: 1-3 months]
- Bioprosthetic Valve Failure [Time frame: 3-5 years]
- Bioprosthetic Valve Failure [Time frame: 9-10 years]
- Structural Valve Deterioration [Time frame: 9-10 years]
Secondary outcome measures (7)
- Hemodynamic Valve Performance [Time frame: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)]
- Bioprosthetic Valve Failure [Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year)]
- Bioprosthetic Valve Dysfunction [Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)]
- Patient reported outcomes [Time frame: 1-3month, 1+3year Follow Up compared to BL]
- Cumulated incidence rate BVD or BVF [Time frame: Up to 10 years]
- Clinical Events [Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)]
- Hemodynamic valve deterioration stage 2 and 3 (VARC-3) [Time frame: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18 years)
- Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve
- Patient is willing to attend the follow-up visits up to 10 years at the center
Exclusion criteria
- Lack of written informed consent
- Emergency procedure
- Pregnancy at time of TAVI
Critieria for long-term observation (1y-10y):
- Technical success at exit from procedure room (VARC-3):
- Freedom from mortality
- Successful access, delivery of the device, and retrieval of the delivery system
- Correct positioning of a single prosthetic heart valve into the proper anatomical location
- Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication
- Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):
- All stroke
- Bleeding type 3-4
- Myocardial infarction
- Need for a second valve
- Valve embolization
- Coronary obstruction
- Annular rupture
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- Heart and Diabetes Center North Rhine-Westphalia — Bad Oeynhausen
Identifiers
NCT: NCT06953206 · RESOUND-EU Registry