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BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Study acronym: BACKBEAT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 37% 500 → 316 participants
See other at-risk trials from Orchestra BioMed, Inc

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 40 of 131 sites
  2. Interventions: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated (Device), Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated… to Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated (Device), Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated…
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 16 of 131 sites
    • Publications: details revised at 2 of 2 entries
  3. Enrollment reduced: 500 → 316 participants
    • Study sites: 130 to 131
    v39
  4. Study sites: 131 to 130v38
  5. Study sites: 129 to 131v37
  6. Trial sites expanded: 99 → 128 locationsv36
  7. Study sites: 99 to 128v35
  8. Study sites: 98 to 99v34
  9. Study sites: 94 to 98v33
  10. Study sites: 87 to 94v32
  11. Study sites: 78 to 87v31
  12. Study sites: 76 to 78v30
  13. Site details revised at 1 of 76 sitesv29
  14. Study sites: 73 to 76v28
  15. Primary completion date: Oct 2026 to Dec 2026v27 Show 4 more changesShow less
    • Study completion date: Jun 2029 to Aug 2029
    • Eligibility criteria shortened, about 8 words
    • Site details revised at 2 of 73 sites
    • Study description expanded, about 4 words
  16. Study sites: 72 to 73v26
  17. Study sites: 67 to 72v25
  18. Study sites: 66 to 67v24
  19. Study sites: 65 to 66v23
  20. Study sites: 64 to 65v22
  21. Study sites: 48 to 64v21
  22. Study sites: 47 to 48v20
  23. Primary completion date: Oct 2025 to Oct 2026
    • Study completion date: Jun 2028 to Jun 2029
    v19
  24. Study sites: 41 to 47v18
  25. Study sites: 40 to 41
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 19 words
    v17
  26. Study sites: 34 to 40v16
  27. Study sites: 30 to 34v15
  28. Study sites: 28 to 30v14
  29. Study sites: 22 to 28v13
  30. Study sites: 21 to 22v12
  31. Study sites: 17 to 21v11
  32. Study sites: 15 to 17v10
  33. Study sites: 12 to 15v9
  34. Study sites: 10 to 12v8
  35. Site details revised at 1 of 10 sitesv7
  36. Site details revised at 3 of 10 sitesv6
  37. Study sites: 9 to 10v5
  38. Study sites: 3 to 9v4
  39. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Nov 2023 to Dec 27, 2023
    v3
  40. Lead sponsor: [Redacted] to Orchestra BioMed, Incv2 Show 6 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Oct 2025
    • Study completion date: Jun 2028
    • Start date: Nov 2023
    • Collaborators expanded, about 1 word
    • Study title shortened, about 3 words
  41. 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.
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
Trial Details
NCT Number NCT06059638
Lead Sponsor Orchestra BioMed, Inc
Collaborators: Medtronic
Conditions
(from sponsor)		 Hypertension, Hypertension, Systolic, Hypertension, Essential
Related terms Essential Hypertension, Hypertension, Isolated Systolic Hypertension
Enrollment 316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov