SAPIEN 3 Ultra System PMCF

Study Overview
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Brief Summary
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A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Detailed Description
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To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Official Title
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SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: SAPIEN 3 Ultra System


Participation Criteria
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Eligibility Criteria
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Subject meets the criteria per the Indication and Contraindications according to the current IFUs. Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator). Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy. Subject has provided written informed consent to comply with all study procedures and follow-up visits
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transcatheter aortic valve implantation<br> | Device: SAPIEN 3 Ultra System<br>* Transcatheter aortic valve implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success per VARC-3, defined as meeting all of the following: | Technical success Freedom from mortality Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1 year | 
| Stroke |  | 30 days and 1 year | 
| Major vascular complications |  | 30 days | 
| Life threatening bleeding |  | 30 days | 
| New conduction defects requiring permanent pacemaker |  | 30 days | 
| Acute kidney injury stage 2-3 |  | 7 days | 
| New onset atrial fibrillation |  | 30 days | 
| Rehospitalization (valve-related or due to worsening heart failure) |  | 1 year | 
| Paravalvular leak |  | 30 days and 1 year | 
| Mean aortic valve gradient |  | 30 days and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, SAPIEN 3 Ultra