SAPIEN 3 Ultra System PMCF

NCT04555967 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Edwards Lifesciences

Phase

Observational

Started

2020-06-30

Last updated

2026-04-15

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

SAPIEN 3 Ultra System

SAPIEN 3 Ultra System: Transcatheter aortic valve implantation

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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)

Trial sites (11)

Facility	City	Region
Medizinische Universitaet Wien	Vienna	Austria
St. Paul's Hospital Vancouver	Vancouver	British Columbia
Aarhus University Hospital, Skejby	Aarhus	Denmark
Helsinki University Hospital	Helsinki	Finland
Charité - Universitätsmedizin Berlin	Berlin	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Universitares Herzzentrum Hamburg	Hamburg	Germany
Ospedale G. Pasquinucci	Massa	Italy
Universitair Medisch Centrum Utrecht	Utrecht	Netherlands
Royal Victoria Hospital Belfast	Belfast	United Kingdom
King's College Hospital London	London	United Kingdom

More Edwards Lifesciences trials in the Netherlands

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR Recruiting

The ENCIRCLE Trial Recruiting

MiCLASP Post Market Clinical Follow-Up (PMCF) Study Active, not recruiting

Other trials for the same condition

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients Active, not recruiting

Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation Recruiting

Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI Active, not recruiting

Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients Active, not recruiting

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04555967 on ClinicalTrials.gov ↗ ← All trials in the Netherlands