Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

NCT06953206 | Not Yet Recruiting

• 1 other identifier: RESOUND-EU Registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

Conditions

Aortic-Stenosis; Transcatheter Aortic Valve Replacement (TAVR); Aortic Insufficiency; Degenerative Valve Disease

Keywords

TAVR; SAPIEN 3 Ultra RESILIA Valve; S3UR; TAVI; Aortic Stenosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Hemodynamic Valve Performance

  All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)

• Bioprosthetic Valve Failure

  All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year)

• Bioprosthetic Valve Dysfunction

  All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)

• Patient reported outcomes

  1-3month, 1+3year Follow Up compared to BL

• Cumulated incidence rate BVD or BVF

  Up to 10 years

Other Outcomes (2)

• Overall kidney function

  All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)

• Overall Lipid Status

  All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)

Study Arms (1)

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)

Interventions

Transcatheter aortic valve (S3UR) replacement (TAVR) PROCEDURE

Elective transfemoral TAVi procedure with S3UR valve.

TAVI Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (1)

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Replantation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Lüske, PhD

CONTACT

044718503324; claudia.lueske@ippmed.de

Beate Botta, PhD

CONTACT

044718503325; beate.botta@ippmed.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 30, 2037
• Study Completion (Estimated): September 30, 2037
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)