deltatrials
Completed NA INTERVENTIONAL 2-arm NCT02439749

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

Sponsor: Medtronic Vascular

Conditions Cardiovascular Diseases Hypertension Vascular Diseases
Interventions Sham Procedure Symplicity Spyral™ multi-electrode renal denervation system
Updated 45 times since 2017 Last updated: Mar 18, 2025 Started: Jun 30, 2015 Primary completion: Apr 30, 2020 Completion: Oct 25, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02439749, this NA trial focuses on Cardiovascular Diseases and Hypertension and remains completed. Sponsored by Medtronic Vascular, it has been updated 45 times since 2015, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Feb 2018 · 4 months · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Jan 2020 · 3 months · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Oct 2020 · 5 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jun 2021 · 3 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jun 2022 · 6 months · monthly snapshot~Jun 2022 – ~Nov 2022 · 5 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~May 2023 · 4 months · monthly snapshot~May 2023 – ~Nov 2023 · 6 months · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~May 2024 · 4 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

45 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed NA

  2. Apr 2025 — Sep 2025 [monthly]

    Completed NA

  3. Sep 2024 — Apr 2025 [monthly]

    Completed NA

  4. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  5. May 2024 — Jul 2024 [monthly]

    Completed NA

▶ Show 40 earlier versions

  1. Jan 2024 — May 2024 [monthly]

    Completed NA

    Status: Active Not Recruiting → Completed

  2. Nov 2023 — Jan 2024 [monthly]

    Active Not Recruiting NA

  3. May 2023 — Nov 2023 [monthly]

    Active Not Recruiting NA

  4. Jan 2023 — May 2023 [monthly]

    Active Not Recruiting NA

  5. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting NA

  6. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting NA

  7. Jun 2022 — Nov 2022 [monthly]

    Active Not Recruiting NA

  8. Dec 2021 — Jun 2022 [monthly]

    Active Not Recruiting NA

  9. Sep 2021 — Dec 2021 [monthly]

    Active Not Recruiting NA

  10. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting NA

  11. Mar 2021 — Jun 2021 [monthly]

    Active Not Recruiting NA

  12. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting NA

  13. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting NA

  14. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting NA

  15. May 2020 — Oct 2020 [monthly]

    Active Not Recruiting NA

    Status: Recruiting → Active Not Recruiting

  16. Apr 2020 — May 2020 [monthly]

    Recruiting NA

  17. Jan 2020 — Apr 2020 [monthly]

    Recruiting NA

  18. Oct 2019 — Jan 2020 [monthly]

    Recruiting NA

  19. Aug 2019 — Oct 2019 [monthly]

    Recruiting NA

  20. Jul 2019 — Aug 2019 [monthly]

    Recruiting NA

  21. Jun 2019 — Jul 2019 [monthly]

    Recruiting NA

  22. May 2019 — Jun 2019 [monthly]

    Recruiting NA

  23. Apr 2019 — May 2019 [monthly]

    Recruiting NA

  24. Mar 2019 — Apr 2019 [monthly]

    Recruiting NA

  25. Jan 2019 — Mar 2019 [monthly]

    Recruiting NA

  26. Dec 2018 — Jan 2019 [monthly]

    Recruiting NA

  27. Nov 2018 — Dec 2018 [monthly]

    Recruiting NA

  28. Oct 2018 — Nov 2018 [monthly]

    Recruiting NA

  29. Sep 2018 — Oct 2018 [monthly]

    Recruiting NA

  30. Aug 2018 — Sep 2018 [monthly]

    Recruiting NA

  31. Jul 2018 — Aug 2018 [monthly]

    Recruiting NA

  32. Jun 2018 — Jul 2018 [monthly]

    Recruiting NA

  33. May 2018 — Jun 2018 [monthly]

    Recruiting NA

  34. Mar 2018 — May 2018 [monthly]

    Recruiting NA

  35. Feb 2018 — Mar 2018 [monthly]

    Recruiting NA

  36. Oct 2017 — Feb 2018 [monthly]

    Recruiting NA

  37. Jul 2017 — Oct 2017 [monthly]

    Recruiting NA

  38. May 2017 — Jul 2017 [monthly]

    Recruiting NA

  39. Feb 2017 — May 2017 [monthly]

    Recruiting NA

    Phase: PHASE2 → NA

  40. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jun 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Medtronic Vascular
Data source: Medtronic Vascular

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

Study Locations

Anderson, United States , Athens, Greece , Atlanta, United States , Bad Krozingen, Germany , Cardiff, United Kingdom , Charleston, United States , Chiyoda City, Japan , Cleveland, United States , Dallas, United States , Durham, United States and 36 more locations