Aortic Valve Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, SAPIEN 3 Ultra
Brief summary
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Detailed description
To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Interventions
DEVICESAPIEN 3 Ultra System
Transcatheter aortic valve implantation
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Subject has provided written informed consent to comply with all study procedures and follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device success per VARC-3, defined as meeting all of the following: | 30 days | * 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) |
Secondary
| Measure | 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 |
Countries
Austria, Canada, Denmark, Finland, Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed