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Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

ConditionsAortic Valve StenosisTranscatheter Aortic Valve Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

About this trial

The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.

Freedom from mortality

Successful access, delivery of the device, and retrieval of the delivery system

Disqualifiers

Age >80 years

Severe pulmonary disease (FEV1 <50% predicted or need for home oxygen)

Severe renal dysfunction (eGFR <30 ml/min/1.73m2)

Frailty (Clinical Frailty Scale > 4)

Trial population

Population Patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA valve.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SAPIEN 3 Ultra RESILIA Valve

    Procedure/Surgery

    Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Transvalvular gradient

Residual (peak and mean) transvalvular gradient

Time frame
1-3 months
2

Effective orifice area (EOA)

EOA evaluated by echocardiography imaging

Time frame
1-3 months
3

Prosthesis-patient mismatch

Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).

Time frame
1-3 months
4

Paravalvular leaks

Paravalvular leaks evaluated by echocardiography imaging

Time frame
1-3 months

Secondary outcomes

1

Transvalvular gradient

Residual (maximal and mean) transvalvular gradient

Time frame
1-, 3-5-, 6-8-, and 9-10-year follow-up.
2

Effective orifice area (EOA)

EOA evaluated by echocardiography imaging

Time frame
1-, 3-5-, 6-8-, and 9-10-year follow-up.
3

Bioprosthetic valve dysfunction

Bioprosthetic valve dysfunction evaluated by VARC3 criteria

Time frame
1-, 3-5-, 6-8-, and 9-10-year follow-up.
4

Paravalvular leaks

Paravalvular leaks evaluated by echocardiography imaging

Time frame
1-, 3-5-, 6-8-, and 9-10-year follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead sponsor

Source ClinicalTrials.gov
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