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Completed

NCT Number: NCT04860752

SAPIEN 3 Ultra EU PMS

This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.

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Key information

Conditions

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

Age range

Up to 79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH-Univ. Graz Klinik, Auenbruggerplaz 15, Graz, Austria

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About this study

This is a prospective, observational, single-arm, multicentre, post-market study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Will undergo TAVI with the Edwards SAPIEN 3 Ultra System
  • Less than 80 years of age at time of the procedure
  • Low surgical risk
  • Meets clinical and procedural requirements for early discharge
  • The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent

Exclusion criteria

  • Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
  • Considered to be part of a vulnerable population
  • Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  • Cannot tolerate an anticoagulation/antiplatelet regimen
  • Active bacterial endocarditis
  • Participating in a drug or device study that has not reached its primary endpoint

Treatment and study plan

Transcatheter Aortic Valve Implantation (TAVI)

Device

Subjects will undergo TAVI

Primary outcomes

  1. Length of Index Hospitalization

    Time frame: Discharge from hospital, expected to be within 1-5 days post-procedure

    Number of days in hospital after the procedure

Secondary outcomes

  1. Death

    Time frame: 1 year

    Number of patients who died

  2. Stroke

    Time frame: 1 year

    Number of patients who had a stroke

  3. New Requirement for Permanent Pacemaker

    Time frame: 1 year

    Number of patients who received a new permanent pacemaker

  4. Aortic Valve Reintervention

    Time frame: 1 year

    Number of patients who required valve reintervention

  5. Aortic Regurgitation

    Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure

    Number of patients who had moderate or greater aortic regurgitation

  6. Mean Gradient

    Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure

    Mean gradient (mmHg)

  7. Effective Orifice Area

    Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure

    Aortic valve area (cm2)

  8. Discharge Location

    Time frame: At discharge from hospital, expected to be within 1-5 days post-procedure

    Number of patients who were discharged to home or self-care (routine discharge)

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

SAPIEN 3 Ultra EU Post-Market Observational Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2021
Registry last updated
Jul 29, 2025

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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