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Completed OBSERVATIONAL NCT01819181

Women's INternational Transcatheter Aortic Valve Implantation Registry (WINTAVI)

Sponsor: Icahn School of Medicine at Mount Sinai

Updated 9 times since 2017 Last updated: May 3, 2018 Started: Mar 31, 2013 Primary completion: May 31, 2016 Completion: Apr 26, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01819181, this observational or N/A phase trial focuses on Symptomatic Aortic Stenosis and remains completed. Sponsored by Icahn School of Medicine at Mount Sinai, it has been updated 9 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

WINTAVI is an international, multi-centre, prospective, observational registry. The purpose of this study is to collect 'real-world' data regarding the clinical utility of all commercially available Transcatheter Aortic Valve Implantation (TAVI) devices for percutaneous aortic valve implantation in female patients with severe Aortic Stenosis (AS) requiring treatment. Data collected in this study will provide additional information on the understanding of the safety and device performance in a 'real-world' setting and how to best treat patients with severe AS. This will include Quality of Life questionnaires (KCCQ).

WINTAVI is an international, multi-centre, prospective, observational registry. The purpose of this study is to collect 'real-world' data regarding the clinical utility of all commercially available Transcatheter Aortic Valve Implantation (TAVI) devices for percutaneous aortic valve implantation in female patients with severe Aortic Stenosis (AS) requiring treatment. Data collected in this study will provide additional information on the understanding of the safety and device performance in a 'real-world' setting and how to best treat patients with severe AS. This will include Quality of Life questionnaires (KCCQ).

Status Flow

~Jan 2017 – ~Mar 2018 · 14 months · monthly snapshotActive Not Recruiting~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshotActive Not Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2025 — Present [monthly]

    Completed

  3. Sep 2024 — Sep 2025 [monthly]

    Completed

  4. Jul 2024 — Sep 2024 [monthly]

    Completed

  5. Jan 2021 — Jul 2024 [monthly]

    Completed

Show 4 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed

    Status: Active Not RecruitingCompleted

  2. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting

    Phase: NANone

  3. Mar 2018 — Apr 2018 [monthly]

    Active Not Recruiting NA

  4. Jan 2017 — Mar 2018 [monthly]

    Active Not Recruiting NA

    First recorded

Mar 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Icahn School of Medicine at Mount Sinai
  • Society for Cardiovascular Angiography and Interventions
Data source: Icahn School of Medicine at Mount Sinai

For direct contact, visit the study record on ClinicalTrials.gov .