deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT04100135

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF)

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches

Sponsor: W.L.Gore & Associates

Conditions Migraine PFO - Patent Foramen Ovale Patent Foramen Ovale
Interventions Actual device PFO closure Sham device PFO closure Thienopyridine (clopidogrel or prasugrel)
Updated 26 times since 2019 Last updated: Dec 12, 2024 Started: Feb 5, 2021 Primary completion: Aug 15, 2024 Completion: Aug 15, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Dissatisfactory enrollment rate with no safety concerns

Other terminated trials from W.L.Gore & Associates

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Listed as NCT04100135, this NA trial focuses on Migraine and PFO - Patent Foramen Ovale and remains terminated or withdrawn. Sponsored by W.L.Gore & Associates, it has been updated 26 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Dec 2020 · 4 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Dec 2022 · 5 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Mar 2023 · 59 days · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Oct 2023 · 2 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshot~Mar 2024 – ~May 2024 · 2 months · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – present · 19 months · monthly snapshot

Change History

26 versions recorded

  1. Jan 2025 — Present [monthly]

    Terminated NA

    Status: Active Not Recruiting → Terminated

  2. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting NA

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  4. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

  5. May 2024 — Jun 2024 [monthly]

    Active Not Recruiting NA

    Status: Recruiting → Active Not Recruiting

▶ Show 21 earlier versions

  1. Mar 2024 — May 2024 [monthly]

    Recruiting NA

  2. Dec 2023 — Mar 2024 [monthly]

    Recruiting NA

  3. Nov 2023 — Dec 2023 [monthly]

    Recruiting NA

  4. Oct 2023 — Nov 2023 [monthly]

    Recruiting NA

  5. Aug 2023 — Oct 2023 [monthly]

    Recruiting NA

  6. Jul 2023 — Aug 2023 [monthly]

    Recruiting NA

  7. May 2023 — Jul 2023 [monthly]

    Recruiting NA

  8. Mar 2023 — May 2023 [monthly]

    Recruiting NA

  9. Jan 2023 — Mar 2023 [monthly]

    Recruiting NA

  10. Dec 2022 — Jan 2023 [monthly]

    Recruiting NA

  11. Jul 2022 — Dec 2022 [monthly]

    Recruiting NA

  12. Apr 2022 — Jul 2022 [monthly]

    Recruiting NA

  13. Sep 2021 — Apr 2022 [monthly]

    Recruiting NA

  14. Apr 2021 — Sep 2021 [monthly]

    Recruiting NA

    Status: Not Yet Recruiting → Recruiting

  15. Jan 2021 — Apr 2021 [monthly]

    Not Yet Recruiting NA

  16. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting NA

  17. Aug 2020 — Dec 2020 [monthly]

    Not Yet Recruiting NA

  18. Apr 2020 — Aug 2020 [monthly]

    Not Yet Recruiting NA

  19. Feb 2020 — Apr 2020 [monthly]

    Not Yet Recruiting NA

  20. Dec 2019 — Feb 2020 [monthly]

    Not Yet Recruiting NA

    Phase: PHASE3 → NA

  21. Oct 2019 — Dec 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • W.L.Gore & Associates
Data source: W.L.Gore & Associates

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

Study Locations

Ann Arbor, United States , Boston, United States , Buffalo, United States , Charleston, United States , Denver, United States , Liverpool, United States , Los Angeles, United States , Loveland, United States , Milwaukee, United States , New Haven, United States and 4 more locations