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ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. 4 versions Re-verified since Oct 7, 2022, no change to tracked fieldsv13-v16
  2. Results first posted: Sep 30, 2021 Primary endpoint revised · Enrollment target: 142 to 101 · Eligibility criteria expanded, about 174 words · 1 morev12 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 142 to 101
    • Eligibility criteria expanded, about 174 words
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of Dec 2020 to Oct 2, 2020 Interventions: Transcatheter Aortic Valve Replacement (TAVR) (Device) to TAVR with CENTERA THV (Device) · Eligibility criteria revised · Study title shortened, about 3 wordsv11 Show 3 more changesShow less
    • Interventions: Transcatheter Aortic Valve Replacement (TAVR) (Device) to TAVR with CENTERA THV (Device)
    • Eligibility criteria revised
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 1000 to confirmed 142 · Study sites: 32 to 23v10 Show 2 more changesShow less
    • Enrollment target: estimated 1000 to confirmed 142
    • Study sites: 32 to 23
  5. Study sites: 30 to 32v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 25 to 30v8
  2. Study sites: 24 to 25v7
  3. Study sites: 21 to 24v6
  4. Study sites: 10 to 21v5
  5. Study sites: 8 to 10v4
  6. Study sites: 3 to 8v3
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Sep 2018 to Sep 18, 2018v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 2018 to Sep 18, 2018
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
Trial Details
NCT Number NCT03517436
Lead Sponsor Edwards Lifesciences
Conditions Aortic Valve Stenosis
Enrollment 101 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov