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International Multicenter Study of the Navitor/Navitor Vision Transcatheter Aortic Valve Platform

Study acronym: Intensive
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints revised (3) Primary endpoint revised · Collaborators reordered · Eligibility criteria expanded, about 1 word · 1 morev2 Show 4 more changesShow less
    • Primary endpoint revised
    • Collaborators reordered
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
INTENSIVE is a prospective, single-arm, multi-center, international, investigator-initiated study of the Navitor/Navitor Vision Transcatheter Aortic Valve (Navitor/Navitor Vision Valve) in patients with symptomatic, severe native aortic stenosis to monitor the outcomes of this valve in a real-world clinical setting.
Trial Details
NCT Number NCT07359898
Lead Sponsor IRCCS Policlinico S. Donato
Collaborators: Abbott, Meditrial SrL
Conditions Severe Native Aortic Stenosis
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov