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NCT01114269

PRE-DETERMINE Cohort Study

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from Brigham and Women's Hospital

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Record History

All 22 versions: 15 with changes below, 7 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Nov 2026 to Nov 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 27 words
    • Primary endpoints: details revised at 1 of 1 entry
    • Site details revised at 7 of 90 sites
    • Publications: details revised at 9 of 9 entries
  2. Collaborators: 5 to 6
    • Publications: 7 to 9
    v21
  3. Primary and study completion dates: Oct 2022 to Nov 2026
    • Secondary endpoints: details revised at 5 of 5 entries
    v20
  4. Enrollment target: 5761 to 5764
    • Primary and study completion dates: Jul 2022 to Oct 2022
    • Publications: details revised at 1 of 7 entries
    v19
  5. Primary and study completion dates: Feb 2021 to Jul 2022
    • Publications: 3 to 7
    v17
Show 9 earlier versionsHide 9 earlier versions
  1. Enrollment target: 5764 to 5761
    • Start date: Jun 2007 to Jul 2007
    • Study description revised
    v16
  2. Eligibility criteria revisedv11
  3. Primary and study completion dates: Feb 2017 to Feb 2021v9 Show 6 more changesShow less
    • Eligibility criteria revised
    • Primary endpoint revised
    • Enrollment target: 5763 to 5764
    • Secondary endpoints: 1 to 5
    • Study description shortened, about 117 words
    • Collaborators: 3 to 5
  4. Primary and study completion dates: Feb 2016 to Feb 2017v8
  5. Enrollment target: estimated 5800 to confirmed 5763
    • Primary and study completion dates: Dec 2015 to Feb 2016
    • Study title revised
    v6
  6. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 95 to 90
    • Primary completion date: Dec 2015
    • Study title revised
    v5
  7. Enrollment target: 5300 to 5800
    • Study sites revised (95)
    v4
  8. Eligibility criteria revised
    • Study sites: 81 to 95
    • Secondary endpoints: details revised at 1 of 1 entry
    v3
  9. Eligibility criteria shortened, about 27 words
    • Study sites: 55 to 81
    • Study completion date: Jun 2013 to Dec 2015
    • Study description shortened, about 4 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation.
Timeframe: Median follow-up estimated to be 10.7 years

Secondary (5)

ICD Shock
ICD Implantation
Total Cardiac Mortality
Total Mortality
Non-Sudden or Arrhythmic Causes of Mortality

Sites

90 sites in 3 countries

United States 86, Canada 3, Puerto Rico 1