Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve (RESOUND-EU)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Insufficiency; Transcatheter Aortic Valve Replacement (TAVR); Aortic-Stenosis; Degenerative Valve Disease
• Intervention / Treatment: Procedure: Transcatheter aortic valve (S3UR) replacement (TAVR)

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Claudia Lüske, PhD; Phone Number: 044718503324; Email: claudia.lueske@ippmed.de
• Study Contact Backup: Name: Beate Botta, PhD; Phone Number: 044718503325; Email: beate.botta@ippmed.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
      • Heart and Diabetes Center North Rhine-Westphalia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patiets with severe aortic stenosis planned to undergo TAVR on their native valve with a SAPIEN 3 Ultra RESILIA Valve.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAVI Patients; Adult patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve	Procedure: Transcatheter aortic valve (S3UR) replacement (TAVR); Elective transfemoral TAVi procedure with S3UR valve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Safety	Early safety acc. to VARC-3	1-3 months
Device Success	Device Success acc. to VARC-3	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))	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))	9-10 years
Structural Valve Deterioration	Structural Valve Deterioration ≥ stage 2 (VARC-3)	9-10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Valve Performance	Prosthetic valve regurgitation including paravalvular regurgitation; Mean transvalvular gradient; Max transvalvular gradient; Effective orifice area	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	All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year)
Bioprosthetic Valve Dysfunction	BVD acc. to VARC-3	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	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	Up to 10 years
Clinical Events	Clinical events (mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization)	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).	All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall kidney function	Kidney function assessed through lab values: eGFR in ml/min/1,73m2; creatinine in mg/dl or micromol/l; albumin-to-creatinin-ratio in mg/g; serum calcium in mg/dl or millimol/l ; serum phosphate in mg/dl or millimol/l ; PTH intact in pmol/l, pg/ml or ng/l; Hb in g/l, g/dl, millimol/l	All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)
Overall Lipid Status	Lipid status assessed through lab values: total cholesterol in mg/dl, millimol/l or micromol/l; LDL in millimol/l or micromol/l; HDL millimol/l or micromol/l;Triglycerides in mg/dl, millimol/l or micromol/l; latest HbA1c in %; Lp(a) in mg/dl or nmol/l	All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Principal Investigator: Tanja Rudolph, Prof., Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University Bochum; Principal Investigator: Michael Joner, Prof, German Heart Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 30, 2037
• Study Completion (Estimated): September 30, 2037

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Stenosis; TAVI; TAVR; SAPIEN 3 Ultra RESILIA Valve; S3UR
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Surgical Procedures, Operative; Transplantation; Replantation
• Other Study ID Numbers: RESOUND-EU Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no individual participant data (IPD) will be shard

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No