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Global SYMPLICITY Registry (GSR) DEFINE

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 2 sitesv35
  2. Re-verified, no change to tracked fieldsv34
  3. Primary completion date: Apr 2026 to Jun 2027 Study sites: 1 to 2 · Completion date: Aug 2031 to Dec 2031v33 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Completion date: Aug 2031 to Dec 2031
  4. Site contact updatedv32
  5. Primary completion date: May 2025 to Apr 2026 Completion date: May 2028 to Aug 2031v31 Show 1 more changeShow less
    • Completion date: May 2028 to Aug 2031
Show 29 earlier versionsHide 29 earlier versions
  1. Re-verified, no change to tracked fieldsv30
  2. Primary completion date: May 2024 to May 2025 Completion date: Oct 2027 to May 2028v29 Show 1 more changeShow less
    • Completion date: Oct 2027 to May 2028
  3. 3 versions Re-verified since Oct 27, 2021, no change to tracked fieldsv26-v28
  4. Enrollment target: 3000 to 5000 Primary completion date: Feb 2022 to May 2024 · Completion date: Oct 2023 to Oct 2027 · Study description shortened, about 8 words · 1 morev25 Show 4 more changesShow less
    • Primary completion date: Feb 2022 to May 2024
    • Completion date: Oct 2023 to Oct 2027
    • Study description shortened, about 8 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. 3 versions Re-verified since Apr 22, 2020, no change to tracked fieldsv22-v24
  6. Primary completion date: Jul 2019 to Feb 2022 Completion date: Mar 2022 to Oct 2023v21 Show 1 more changeShow less
    • Completion date: Mar 2022 to Oct 2023
  7. 2 versions Re-verified since Oct 26, 2018, no change to tracked fieldsv19-v20
  8. Primary completion date: Jul 2018 to Jul 2019v18
  9. Re-verified, no change to tracked fieldsv17
  10. Primary completion date: Nov 2017 to Jul 2018 Completion date: Apr 2021 to Mar 2022v16 Show 1 more changeShow less
    • Completion date: Apr 2021 to Mar 2022
  11. Site details revisedv15
  12. Primary completion date: Jul 2017 to Nov 2017 Completion date: Jul 2021 to Apr 2021v14 Show 1 more changeShow less
    • Completion date: Jul 2021 to Apr 2021
  13. Re-verified, no change to tracked fieldsv13
  14. Enrollment target: 5000 to 3000 Site contact updatedv12 Show 1 more changeShow less
    • Site contact updated
  15. Primary completion date: Aug 2016 to Jul 2017v11
  16. 4 versions Re-verified since May 9, 2014, no change to tracked fieldsv7-v10
  17. Phase: Phase 4 to Not specifiedv6
  18. 4 versions Re-verified since Apr 24, 2012, no change to tracked fieldsv2-v5
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.
Trial Details
NCT Number NCT01534299
Lead Sponsor Medtronic Vascular
Conditions Hypertension
Enrollment 5,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov