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

Institut für Pharmakologie und Präventive Medizin

Status: Not yet enrolling

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

Treatments: Procedure: Transcatheter aortic valve (S3UR) replacement (TAVR)

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06953206

RESOUND-EU Registry

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

TAVI Patients

Description:

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

Treatment:

Procedure: Transcatheter aortic valve (S3UR) replacement (TAVR)