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Assessment of Combined CCM and ICD Device in HFrEF

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

Record History

  1. Primary completion date: Jan 2026 to May 2026 Study sites revised (59)v33 Show 1 more changeShow less
    • Study sites revised (59)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jun 2025 to Jan 2026 Trial status: Recruiting to Active, Not Recruiting · Study sites: 65 to 59 · Completion date: Dec 2025 to Jul 2027v32 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 65 to 59
    • Completion date: Dec 2025 to Jul 2027
  3. Study sites: 63 to 65v31
  4. Site contacts updated at 1 of 63 sitesv30
  5. Study sites: 56 to 63v29
Show 27 earlier versionsHide 27 earlier versions
  1. Study sites: 54 to 56v28
  2. Re-verified, no change to tracked fieldsv27
  3. Study sites: 53 to 54v26
  4. Study sites: 51 to 53v25
  5. Study sites: 46 to 51v24
  6. Study sites: 45 to 46v23
  7. Study sites: 43 to 45v22
  8. Study sites: 42 to 43v21
  9. Study sites: 37 to 42v20
  10. Primary completion date: Jun 2024 to Jun 2025 Study sites: 36 to 37v19 Show 1 more changeShow less
    • Study sites: 36 to 37
  11. Study sites: 28 to 36v18
  12. Study sites: 24 to 28v17
  13. Study sites: 22 to 24v16
  14. Study sites: 21 to 22v15
  15. Study sites: 20 to 21v14
  16. Study sites: 19 to 20v13
  17. Study sites: 15 to 19v12
  18. Study sites: 14 to 15v11
  19. Study sites: 13 to 14v10
  20. Study sites: 12 to 13v9
  21. Study sites: 11 to 12v8
  22. Study sites: 9 to 11v7
  23. Study sites: 8 to 9v6
  24. Study sites: 7 to 8v5
  25. Study sites: 6 to 7v4
  26. Study sites: 5 to 6v3
  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of May 2023 to May 17, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of May 2023 to May 17, 2023
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
Trial Details
NCT Number NCT05855135
Lead Sponsor Impulse Dynamics
Conditions Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac +2 more
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov