NCT04555967

Brief Summary

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

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
8 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jun 2020Nov 2026

Study Start

First participant enrolled

June 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2021

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

September 1, 2020

Last Update Submit

April 10, 2026

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve ImplantationTranscatheter Aortic Valve ReplacementSAPIEN 3 Ultra

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

Transcatheter aortic valve implantation

Device: SAPIEN 3 Ultra System

Interventions

SAPIEN 3 Ultra SystemDEVICE

Transcatheter aortic valve implantation

Transcatheter aortic valve implantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Medizinische Universitaet Wien

Vienna, 1090, Austria

Location

St. Paul's Hospital Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Helsinki University Hospital

Helsinki, 00100, Finland

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Universitares Herzzentrum Hamburg

Hamburg, 20251, Germany

Location

Ospedale G. Pasquinucci

Massa, 54100, Italy

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Royal Victoria Hospital Belfast

Belfast, BT12 6BA, United Kingdom

Location

King's College Hospital London

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 21, 2020

Study Start

June 30, 2020

Primary Completion

September 24, 2021

Study Completion (Estimated)

November 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)FI(1)GB(2)AU(1)IT(1)NL(1)DK(1)CA(1)