Transcatheter Aortic Valve Replacement (TAVR)RESOUND-EUNCT06953206
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
An observational study of Transcatheter Aortic Valve Replacement (TAVR) and Aortic-Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 1 site in Germany.
Trial summary
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency
- What is being tested?
- Transcatheter aortic valve (S3UR) replacement (TAVR)
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2025to 30 Sep 2037
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patiets with severe aortic stenosis planned to undergo TAVR on their native valve with a SAPIEN 3 Ultra RESILIA Valve.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, 32545
Tanja Rudolph, Prof., 05731971276, trudolph@hdz-nrw.de
About this study
Official title: SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Read the 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
- Being tested
- Transcatheter aortic valve (S3UR) replacement (TAVR)
- Keywords
- TAVR, SAPIEN 3 Ultra RESILIA Valve, S3UR, TAVI, Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve (S3UR) replacement (TAVR)Procedure or surgery
Elective transfemoral TAVi procedure with S3UR valve.
| Study group | Role | What they receive |
|---|---|---|
| TAVI Patients | Adult patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve Receives: Procedure: Transcatheter aortic valve (S3UR) replacement (TAVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Safety
Early safety acc. to VARC-3
Measured: 1-3 months
Device Success
Device Success acc. to VARC-3
Measured: 1-3 months
Bioprosthetic Valve Failure
Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operations/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))
Measured: 3-5 years
Bioprosthetic Valve Failure
Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operation/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))
Measured: 9-10 years
Structural Valve Deterioration
Structural Valve Deterioration ≥ stage 2 (VARC-3)
Measured: 9-10 years
Secondary outcomes (7)
Hemodynamic Valve Performance
- Prosthetic valve regurgitation including paravalvular regurgitation
- Mean transvalvular gradient
- Max transvalvular gradient
- Effective orifice area
Measured: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)
Bioprosthetic Valve Failure
Bioprosthetic Valve Failure acc. to VARC-3
Measured: All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year)
Bioprosthetic Valve Dysfunction
BVD acc. to VARC-3
Measured: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)
Patient reported outcomes
Patient reported outcomes using TASQ questionnaire and EQ-5D questionnaire
Measured: 1-3month, 1+3year Follow Up compared to BL
Cumulated incidence rate BVD or BVF
Cumulated incidence rate (per 100 patient-years) of bioprosthetic valve dysfunction (stage 2 or 3) OR bioprosthetic valve failure up to 10-year follow-up
Measured: Up to 10 years
Clinical Events
Clinical events (mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization)
Measured: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)
Hemodynamic valve deterioration stage 2 and 3 (VARC-3)
HVD stage 2 and 3 according to VARC-3 Criteria (moderate and severe HVD).
Measured: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Sep 2025
- Primary completion30 May 2037 (estimated)
- Study completion30 Sep 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Replacement (TAVR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tanja Rudolph, Prof., Principal investigator, Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University BochumMichael Joner, Prof, Principal investigator, German Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953206
- Sponsor's protocol ID
- RESOUND-EU Registry
- Acronym
- RESOUND-EU
- Status last verified
- Mar 2026
- First submitted
- 16 Apr 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data (IPD) will be shard