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SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 93 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 98 to 97v93
  2. Study sites: 99 to 98v92
  3. Study sites revised (99)v91 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion moved earlier from Nov 30, 2026 to Mar 5, 2026v90
  5. Study sites revised (99)v89 See this version in full on ClinicalTrials.gov ↗
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 100 to 99v88
  2. Site details revised at 1 of 100 sitesv87
  1. Enrollment increased: 1300 → 1899 participantsv86
  2. 2 versions Re-verified since Oct 16, 2025, no change to tracked fieldsv84-v85
  3. Enrollment target: 1400 to 1300v83
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 100 of 100 sitesv82 Show 1 more changeShow less
    • Site details revised at 100 of 100 sites
  5. 2 versions Re-verified since Jul 24, 2025, no change to tracked fieldsv80-v81
  6. Site contacts updated at 1 of 100 sitesv79
  7. Study sites: 99 to 100v78
  8. Site details revised at 1 of 99 sitesv77
  9. Study sites: 98 to 99 Secondary endpoints: details revised at 10 of 11 entriesv76 Show 1 more changeShow less
    • Secondary endpoints: details revised at 10 of 11 entries
  10. Site contacts updated at 1 of 98 sitesv75
  11. Study sites: 96 to 98v74
  12. Study sites revised (96)v73 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 95 to 96v72
  14. Site contacts updated at 1 of 95 sitesv71
  15. Site details revised at 1 of 95 sitesv70
  16. Study sites: 94 to 95v69
  17. Site contacts updated at 1 of 94 sitesv68
  18. Study sites: 93 to 94v67
  19. Study sites: 92 to 93v66
  20. Study sites: 91 to 92v65
  21. Site contacts updated at 81 of 91 sitesv64
  22. Study sites: 90 to 91v63
  23. Study sites: 89 to 90v62
  24. Study sites: 88 to 89v61
  25. Study sites: 87 to 88v60
  26. Study sites: 86 to 87v59
  27. Study sites: 85 to 86v58
  28. Study sites: 84 to 85v57
  29. Study sites: 83 to 84v56
  30. Study sites: 82 to 83v55
  31. Study sites revised (82)v54 See this version in full on ClinicalTrials.gov ↗
  32. Study sites: 81 to 82v53
  33. Study sites: 80 to 81v52
  34. Study sites: 79 to 80v51
  35. Enrollment target: 1200 to 1400 Site contacts updated at 1 of 79 sitesv50 Show 1 more changeShow less
    • Site contacts updated at 1 of 79 sites
  36. Study sites: 76 to 79v49
  37. Site contacts updated at 2 of 76 sitesv48
  38. Study sites: 74 to 76v47
  39. Study sites: 72 to 74v46
  40. Study sites: 71 to 72v45
  41. Study sites: 69 to 71v44
  • 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.
Medtronic Vascular
11 trials monitored
See all monitored trials
Diabetes
4,286 trials monitored
See 187 trials at risk
Heart Disease
2,136 trials monitored
See 109 trials at risk
Hypertension
1,795 trials monitored
See 85 trials at risk
and 1 more disease
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.
Trial Details
NCT Number NCT05198674
Lead Sponsor Medtronic Vascular
Conditions Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
Enrollment 1,899 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov