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SAPIEN 3 Ultra EU PMS

NCT04860752 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-07-29

Study results available
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Summary

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.

Conditions

  • Aortic Stenosis
  • Aortic Valve Stenosis

Interventions

DEVICE

Transcatheter Aortic Valve Implantation (TAVI)

Subjects will undergo TAVI

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2024-07-22
Completion
2024-07-22

Countries

  • Austria
  • Finland
  • France
  • Germany
  • Italy
  • Norway
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860752 on ClinicalTrials.gov