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

NCT ID: NCT06953206

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2037-09-30

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

TAVI Patients

Adult patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve

Transcatheter aortic valve (S3UR) replacement (TAVR)

Intervention Type: PROCEDURE

Elective transfemoral TAVi procedure with S3UR valve.

Interventions

Transcatheter aortic valve (S3UR) replacement (TAVR)

Elective transfemoral TAVi procedure with S3UR valve.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanja Rudolph, Prof.

Role: PRINCIPAL_INVESTIGATOR

Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University Bochum

Michael Joner, Prof

Role: PRINCIPAL_INVESTIGATOR

German Heart Center

Locations

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, Germany

Countries

Germany

Central Contacts

Claudia Lüske, PhD

Role: CONTACT

claudia.lueske@ippmed.de

044718503324

Beate Botta, PhD

Role: CONTACT

beate.botta@ippmed.de

044718503325

Other Identifiers

RESOUND-EU Registry

Identifier Type: -

Identifier Source: org_study_id