Clinical trial NCT06953206: Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Official title: Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transcatheter Aortic Valve Replacement (TAVR)
Aortic-Stenosis
Aortic Insufficiency
Degenerative Valve Disease
Keywords: TAVR
SAPIEN 3 Ultra RESILIA Valve
S3UR
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2025-05-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Age \>80years
* Severe pulmonary disease (FEV1 \<50% predicted or need for home oxygen)
* Severe renal dysfunction (eGFR \<30ml/min/1.73m2)
* Frailty (Clinical Frailty Scale \>4)
* Severe coronary disease (SYNTAX score \>32)
* Left ventricular ejection fraction ≤30%
* Moderate-to-severe mitral regurgitation
* Severe tricuspid regurgitation
* Pulmonary systolic pressure \>60 mmHg
* STS-PROM \>5%
* Any disease leading to a life expectancy \<5 years

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 (TAVR) 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 TAVR field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVR have been systematically \<10% in all studies, 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. Thus, the objective of this stufy is to evaluate the valve hemodynamics of the SAPIEN 3 Ultra RESILIA valve (S3UR) over a long-time period.

Eligibility criteria: Inclusion Criteria:

1. Patients with severe aortic stenosis undergoing transfemoral TAVI with S3UR valve
2. Successful implantation of the S3UR valve
3. VARC-3 defined technical succes is defined as:

   * 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 ( exluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication

Exclusion Criteria:

-

Primary outcomes:
measure: Valve performance based on VARC-3 criteria
timeFrame: 1-3 months
measure: Valve performance based on VARC-3 criteria
timeFrame: 1-3 months
measure: Valve performance based on VARC-3 criteria
timeFrame: 1-3 months
measure: Valve performance based on VARC-3 criteria
timeFrame: 1-3 months
measure: Valve performance based on VARC-3 criteria
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
Secondary outcomes:
measure: Valve hemodynamics based on VARC-3 criteria
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: All-cause mortality based on VARC-3 criteria
timeFrame: 12 month, discretionary at 5 and 10 years
measure: Valve hemodynamics based on VARC-3 criteria
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Valve hemodynamics based on VARC-3 criteria
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Valve performance based on VARC-3 criteria
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Bioprosthetic valve dysfunction (stage 2 or 3)
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Valve performance based on VARC-3 criteria
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Cardiovascular mortality based on VARC-3 criteria
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Valve-related mortality
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Non-cardiovascular mortality
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Timing of mortality
timeFrame: 30 days
measure: Early mortality
timeFrame: 30 days, 12 month
measure: Late mortality
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Neurologic event -Stroke
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Bleeding type 2-4
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
measure: Cardiac -rehospitalization
timeFrame: 1 month, 12 month, discretionary 5-10 years follow up
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center North Rhine-Westphalia
state: North Rhine-Westphalia
Study officials:
affiliation: Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University Bochum
name: Tanja Rudolph, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Heart Center
name: Michael Joner, Prof
role: PRINCIPAL_INVESTIGATOR
References: