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CTSN Embolic Protection Trial

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Trial sites reduced: 29 → 24 locations
  2. Study sites: 28 to 29
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 28 of 38 entries
    • Study description expanded, about 2 words
  3. Site details revised at 13 of 28 sitesv11
  4. Site details revised at 1 of 28 sitesv10
  5. Site contacts updated at 1 of 28 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 30 words
    • Site details revised at 1 of 28 sites
    v8
  2. Secondary endpoints: details revised at 2 of 38 entries
    • Site details revised at 4 of 28 sites
    v7
  3. Study sites: 22 to 28v6 Show 4 more changesShow less
    • Start date: Sep 6, 2023 to Sep 18, 2023
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 33 to 38
    • Study description expanded, about 187 words
  4. Study sites: 19 to 22
    • Secondary endpoints: 37 to 33
    v5
  5. Study sites: 18 to 19v4
  6. Start date: Sep 1, 2023 to Sep 6, 2023v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 19 to 18
    • Start date changed from estimate of Sep 2023 to Sep 1, 2023
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Trial Details
NCT Number NCT06027788
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Disease, Coronary Artery Disease
Related terms Acute Kidney Injury, Coronary Artery Disease, Delirium, Heart Valve Diseases, Ischemic Stroke
Enrollment 842 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov