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Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)

Study acronym: ASCEND
StatusActive, Not Recruiting
PhaseNot specified
SponsorJOTEC GmbH
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Mar 31, 2024 to Feb 6, 2024
    • Secondary endpoints: details revised at 16 of 16 entries
    • Study description expanded, about 42 words
    v6
  2. Primary completion date: Jan 31, 2024 to Mar 31, 2024v5
  3. Trial status: Recruiting to Active, Not Recruitingv4 Show 4 more changesShow less
    • Enrollment target: estimated 150 to confirmed 108
    • Study sites: 2 to 11
    • Primary completion date: Dec 1, 2023 to Jan 31, 2024
    • Study completion date: Mar 31, 2034 to Mar 31, 2029
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
JOTEC GmbH
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Heart Disease
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The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
Trial Details
NCT Number NCT05082454
Lead Sponsor JOTEC GmbH
Conditions
(from sponsor)		 Aortic Valve Disease
Related terms Aneurysm, Aortic Valve Disease, Constriction, Pathologic
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov