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Pericardiotomy in Cardiac Surgery

Study acronym: PRINCE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 3 to 4v6
  2. Minor Site details revised at 1 of 3 sitesv5
  3. Minor Site details revised at 1 of 3 sitesv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Primary completion date: Sep 2027 to Sep 1, 2027 · Completion date: Sep 2031 to Sep 1, 2031 · 3 morev3 Show 6 more changesShow less
    • Study sites: 0 to 3
    • Primary completion date: Sep 2027 to Sep 1, 2027
    • Completion date: Sep 2031 to Sep 1, 2031
    • Start date changed from estimate of Sep 2024 to Oct 21, 2024
    • Secondary endpoints: 8 to 7
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. Notable Primary endpoints revised (2) Eligibility criteria shortened, about 5 words · Study description expanded, about 3 wordsv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 5 words
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.
Trial Details
NCT Number NCT06486636
Lead Sponsor Population Health Research Institute
Collaborators: McMaster University, Hamilton Health Sciences Corporation, Weill Medical College of Cornell University
Conditions Atrial Fibrillation, Atrial Flutter, Cardiac Events
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov