Long-term outcomes with the SAPIEN 3 Ultra RESILIA heart valve in adults
Official title: SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry
Run by Institut für Pharmakologie und Präventive Medizin · NCT06953206 · Data updated 2026-11-12
This study tests how the SAPIEN 3 Ultra RESILIA valve performs over 10 years in adults undergoing transfemoral TAVR for severe aortic valve disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Institut für Pharmakologie und Präventive Medizin Research network |
| Locations | 1 site (Bad Oeynhausen, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | May 30, 2037 |
| Study ends | September 30, 2037 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT06953206 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with severe aortic stenosis undergoing transfemoral TAVI using the S3UR valve and willing to attend up to 10 years of follow-up.
✕Probably not a fit
Patients who cannot complete long-term follow-up or have contraindications to valve durability assessments may not benefit from the full scope of long-term data.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective registry follows adults receiving the SAPIEN 3 Ultra RESILIA valve via transfemoral TAVR to monitor clinical outcomes and valve performance for up to 10 years. It uses real-world practice to describe durability, safety, and device-related events using VARC-3 criteria. The study aims to characterize long-term valve function, survival, and need for additional interventions in a population often aging with degenerative valve disease. Enrollment is limited to patients who consent and plan follow-up visits at the center. Results will inform durability and safety expectations for the S3UR valve over a decade.
Why it matters
Potential benefit: If successful, patients may gain confidence in the long-term durability and safety of the SAPIEN 3 Ultra RESILIA valve after TAVR.
How similar studies have gone: Prior studies have shown variable but generally favorable durability of bioprosthetic valves up to 8–10 years; this registry adds long-term, real-world data for the S3UR valve.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Tanja Rudolph, Prof. — Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University Bochum
- Study coordinator: Claudia Lüske, PhD
- Email: claudia.lueske@ippmed.de
- Phone: 044718503324
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
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Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
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CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
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CHORDS Cerebral Protection During TAVR
This study tests whether using the CHORDS Cerebral Protection System during TAVR reduces brain embolic events compared to the Sentinel system in adults with severe aortic stenosis.
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Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis
This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.