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Active, Not Recruiting

NCT Number: NCT04555967

SAPIEN 3 Ultra System PMCF

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universitaet Wien, Vienna, Austria

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • Subject has provided written informed consent to comply with all study procedures and follow-up visits

Treatment and study plan

SAPIEN 3 Ultra System

Device

Transcatheter aortic valve implantation

Primary outcomes

  1. Device success per VARC-3, defined as meeting all of the following:

    Time frame: 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 outcomes

  1. Death

    Time frame: 1 year

  2. Stroke

    Time frame: 30 days and 1 year

  3. Major vascular complications

    Time frame: 30 days

  4. Life threatening bleeding

    Time frame: 30 days

  5. New conduction defects requiring permanent pacemaker

    Time frame: 30 days

  6. Acute kidney injury stage 2-3

    Time frame: 7 days

  7. New onset atrial fibrillation

    Time frame: 30 days

  8. Rehospitalization (valve-related or due to worsening heart failure)

    Time frame: 1 year

  9. Paravalvular leak

    Time frame: 30 days and 1 year

  10. Mean aortic valve gradient

    Time frame: 30 days and 1 year

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
Sep 21, 2020
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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