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Band Versus Ring for Tricuspid Regurgitation

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2028v7 Show 4 more changesShow less
    • Start date: Jan 1, 2022 to Jan 1, 2025
    • Trial status: Recruiting to Enrolling by Invitation
    • Eligibility criteria shortened, about 88 words
    • Site details revised
  2. Lead sponsor: The First Affiliated Hospital with Nanjing Medical University to Nanjing Medical Universityv6 Show 4 more changesShow less
    • Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025
    • Start date: Jan 1, 2021 to Jan 1, 2022
    • Primary endpoint revised
    • Collaborators shortened, about 5 words
  3. Lead sponsor: Nanjing Medical University to The First Affiliated Hospital with Nanjing Medical University
    • Primary and study completion dates: Dec 2022 to Dec 31, 2024
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2021 to Jan 1, 2021
    • Collaborators expanded, about 5 words
    v4
  5. Primary and study completion dates: Dec 2021 to Dec 2022
    • Start date: Nov 2019 to Jan 2021
    v3
  6. Eligibility criteria expanded, about 43 wordsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. This study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.
Trial Details
NCT Number NCT04093297
Lead Sponsor Nanjing Medical University
Conditions
(from sponsor)		 Tricuspid Regurgitation
Related terms Tricuspid Valve Insufficiency
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov