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Clinical Trials in the UK / NCT04555967
Active, not recruiting Observational

SAPIEN 3 Ultra System PMCF

NCT04555967 · tracked via the Priya Life Science UK 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
No
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)

FacilityCityRegionStatus
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 UK

The ENCIRCLE Trial Active, not recruiting
MiCLASP Post Market Clinical Follow-Up (PMCF) Study Active, not recruiting
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) Recruiting
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve Active, not recruiting

Other trials for the same condition

Hydra Registry - UK Recruiting
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial Active, not recruiting
ACURATE neo2™ Post Market Clinical Follow up Study Active, not recruiting
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation Enrolling by invitation
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 UK