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A Study of the ReCor Medical Paradise System in Clinical Hypertension

Study acronym: RADIANCE-HTN
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion date: May 2025 to May 2027v58
  2. Results first posted: Jun 28, 2024
    • Primary endpoints: 1 to 2
    • Enrollment target: estimated 292 to confirmed 282
    • Secondary endpoints revised (14)
    v57
  3. 3 versions Re-verified since Mar 30, 2021, no change to tracked fieldsv54-v56
  4. Study sites: 53 to 49v53
  5. 2 versions Re-verified since Oct 6, 2020, no change to tracked fieldsv51-v52
Show 42 earlier versionsHide 42 earlier versions
  1. Primary completion date: Jun 2020 to Sep 2020
    • Study completion date: Aug 2021 to May 2025
    v50
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 58 to 53
    • Primary completion date: Mar 2020 to Jun 2020
    v49
  3. Study sites: 57 to 58v48
  4. Study sites: 56 to 57
    • Eligibility criteria expanded, about 17 words
    v47
  5. Study sites revised (56)v46
  6. Study sites: 53 to 56v45
  7. Study sites: 51 to 53v44
  8. Site details revised at 1 of 51 sitesv43
  9. Study sites: 50 to 51v42
  10. Primary completion date: Aug 2018 to Mar 2020
    • Study sites: 49 to 50
    v41
  11. Study sites: 48 to 49v40
  12. Site details revised at 3 of 48 sitesv39
  13. Site details revised at 1 of 48 sitesv38
  14. Study sites: 46 to 48v37
  15. Site contacts updated at 5 of 46 sitesv36
  16. Study sites: 45 to 46v35
  17. Study sites: 44 to 45v34
  18. Site details revised at 2 of 44 sitesv33
  19. Study sites: 43 to 44v32
  20. Site contacts updated at 2 of 43 sitesv31
  21. Study sites: 40 to 43v30
  22. Study sites: 39 to 40v29
  23. Study sites: 38 to 39v28
  24. Primary completion date: Aug 2017 to Aug 2018
    • Study sites: 37 to 38
    • Study completion date: Jul 2020 to Aug 2021
    v27
  25. Study sites: 35 to 37v26
  26. Study sites: 24 to 35v25
  27. Study sites: 23 to 24v24
  28. Study sites: 22 to 23v23
  29. Study sites: 21 to 22v22
  30. Study sites: 19 to 21v21
  31. Study Status, Eligibilityv20
  32. Site contacts updated at 1 of 19 sitesv19
  33. Site details revised at 1 of 19 sitesv18
  34. Study sites: 17 to 19v17
  35. Site contacts updated at 2 of 17 sitesv16
  36. Study sites: 16 to 17v15
  37. Site contacts updated at 2 of 16 sitesv14
  38. Site details revised at 1 of 16 sitesv13
  39. Site contacts updated at 1 of 16 sitesv12
  40. Study sites: 15 to 16v11
  41. Site details revised at 3 of 15 sitesv10
  42. Study sites: 13 to 15v9
  • 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.
RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.
Trial Details
NCT Number NCT02649426
Lead Sponsor ReCor Medical, Inc.
Conditions
(from sponsor)		 Hypertension, Vascular Diseases
Related terms Essential Hypertension, Hypertension, Vascular Diseases
Enrollment 282 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov