Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Study acronym: SOLVE-CRT
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Jun 2026 → Nov 2027
See other at-risk trials from EBR Systems, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 2026 to Nov 2027
    • Eligibility criteria shortened, about 57 words
    • Site details revised at 5 of 68 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jun 2025 to Jun 2026v47
  3. 6 versions Re-verified since Aug 5, 2024, no change to tracked fieldsv41-v46
  4. Primary and study completion dates: Apr 2024 to Jun 2025v40
  5. 4 versions Re-verified since Sep 19, 2023, no change to tracked fieldsv36-v39
Show 34 earlier versionsHide 34 earlier versions
  1. Study sites revised (68)v35
  2. Re-verified, no change to tracked fieldsv34
  3. Study sites: 69 to 68v33
  4. Study sites: 81 to 69v32
  5. Enrollment target: 192 to 300
    • Primary completion date: Apr 2023 to Apr 2024
    • Study completion date: Dec 2025 to Apr 2024
    • Secondary endpoints: details revised at 1 of 5 entries
    v31
  6. Primary completion date: Dec 2022 to Apr 2023v30
  7. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 84 to 81
    v29
  8. Re-verified, no change to tracked fieldsv28
  9. Study sites: 60 to 84v27
  10. Primary completion date: Dec 2021 to Dec 2022
    • Study sites: 59 to 60
    • Eligibility criteria shortened, about 6 words
    v26
  11. Study sites: 58 to 59v25
  12. Study sites: 57 to 58v24
  13. Trial status: Active, Not Recruiting to Recruitingv23 Show 8 more changesShow less
    • Enrollment target: 350 to 192
    • Primary endpoints: 4 to 2
    • Study sites: 66 to 57
    • Primary completion date: Jun 2021 to Dec 2021
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: 2 to 5
    • Study title shortened, about 7 words
    • Study arms: 2 to 1
  14. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 66 of 66 sites
    v22
  15. Study sites: 60 to 66v21
  16. Primary completion date: Sep 2019 to Jun 2021
    • Study sites: 50 to 60
    • Study completion date: Nov 2020 to Dec 2025
    v20
  17. Site details revised at 1 of 50 sitesv19
  18. Study completion date: Sep 2020 to Nov 2020
    • Eligibility criteria expanded, about 269 words
    • Study description revised
    v18
  19. Study sites: 48 to 50v17
  20. Site details revised at 5 of 48 sitesv16
  21. Study sites: 46 to 48v15
  22. Study sites: 45 to 46v14
  23. Study sites: 43 to 45v13
  24. Study sites: 42 to 43v12
  25. Study sites: 38 to 42v11
  26. Phase: Phase 3 to Not applicable
    • Study sites: 37 to 38
    v10
  27. Study sites: 31 to 37v9
  28. Study sites: 29 to 31v8
  29. Study sites: 31 to 29v7
  30. Study sites: 23 to 31v6
  31. Site details revised at 8 of 23 sitesv5
  32. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2017 to Jan 17, 2018
    • Study sites: 0 to 23
    • Study title expanded, about 2 words
    v4
  33. Re-verified, no change to tracked fieldsv3
  34. Start date: May 2017 to Sep 2017
    • Primary completion date: Jun 2019 to Sep 2019
    • Study completion date: Aug 2020 to Sep 2020
    v2
  1. Study First Submitted
  • 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.
EBR Systems, Inc.
4 trials monitored
See 1 trial at risk
Heart Disease
8,814 trials monitored
See 428 trials at risk
Heart Failure
2,000 trials monitored
See 115 trials at risk
This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
Trial Details
NCT Number NCT02922036
Lead Sponsor EBR Systems, Inc.
Conditions
(from sponsor)		 Heart Failure
Related terms Heart Failure
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov