SAPIEN 3 Ultra System PMCF

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: SAPIEN 3 Ultra System

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medizinische Universitaet Wien
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital Vancouver
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital, Skejby
• Finland
  • Helsinki, Finland, 00100
    • Helsinki University Hospital
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Hamburg, Germany, 20251
    • Universitäres Herzzentrum Hamburg
• Italy
  • Massa, Italy, 54100
    • Ospedale G. Pasquinucci
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital Belfast
  • London, United Kingdom, SE5 9RS
    • King's College Hospital London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with symptomatic, severe, calcific aortic stenosis treated per the indications for use in the Instructions for Use

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transcatheter aortic valve implantation	Device: SAPIEN 3 Ultra System; Transcatheter aortic valve implantation

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): September 24, 2021
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation; SAPIEN 3 Ultra
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2018-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes