deltatrials
Completed NA INTERVENTIONAL 1-arm NCT02656290

COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement (COMMENCE-P)

Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

Sponsor: Edwards Lifesciences

Updated 17 times since 2017 Last updated: Nov 1, 2023 Started: Dec 31, 2015 Primary completion: Sep 30, 2018 Completion: Nov 28, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Congenital Pulmonary Valve Abnormality and Pulmonary Valve Degeneration and is currently completed. Edwards Lifesciences leads this study, which shows 17 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshot~Oct 2018 – ~Oct 2019 · 12 months · monthly snapshot~Oct 2019 – ~Feb 2020 · 4 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Sep 2020 · 5 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Apr 2022 · 11 months · monthly snapshot~Apr 2022 – ~Mar 2023 · 11 months · monthly snapshot~Mar 2023 – ~Dec 2023 · 9 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

17 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Dec 2023 — Jul 2024 [monthly]

    Completed NA

  4. Mar 2023 — Dec 2023 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  5. Apr 2022 — Mar 2023 [monthly]

    Active Not Recruiting NA

Show 12 earlier versions
  1. May 2021 — Apr 2022 [monthly]

    Active Not Recruiting NA

  2. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting NA

  3. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting NA

  4. Apr 2020 — Sep 2020 [monthly]

    Active Not Recruiting NA

  5. Feb 2020 — Apr 2020 [monthly]

    Active Not Recruiting NA

  6. Oct 2019 — Feb 2020 [monthly]

    Active Not Recruiting NA

  7. Oct 2018 — Oct 2019 [monthly]

    Active Not Recruiting NA

  8. Aug 2018 — Oct 2018 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  9. Jun 2018 — Aug 2018 [monthly]

    Recruiting NA

  10. Aug 2017 — Jun 2018 [monthly]

    Recruiting NA

  11. Feb 2017 — Aug 2017 [monthly]

    Recruiting NA

  12. Jan 2017 — Feb 2017 [monthly]

    Recruiting NA

    First recorded

Dec 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Edwards Lifesciences
Data source: Edwards Lifesciences

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

Study Locations