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Impact of Beta Blockers on TAVI (BETA-TAVI)

Study acronym: BETA-TAVI
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jan 30, 2025 to Jan 30, 2028 · Start date changed from estimate of Mar 1, 2024 to Jun 1, 2024 · Study sites: 0 to 2 · 3 morev5 Show 6 more changesShow less
    • Primary completion date: Jan 30, 2025 to Jan 30, 2028
    • Start date changed from estimate of Mar 1, 2024 to Jun 1, 2024
    • Study sites: 0 to 2
    • Completion date: Jan 31, 2025 to Jan 31, 2028
    • Eligibility criteria expanded, about 11 words
    • Study description expanded, about 120 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv4
  3. Enrollment target: 600 to 347 Start date: Mar 1, 2023 to Mar 1, 2024 · Study description revisedv3 Show 2 more changesShow less
    • Start date: Mar 1, 2023 to Mar 1, 2024
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  4. Phase: Phase 3 to Phase 4 Study description shortened, about 1 wordv2 Show 1 more changeShow less
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a prospective, multicentre, investigator-initiated, randomized clinical trial clinical trial investigating the impact of beta-blockers administration among patients undergoing TAVI for severe aortic valve stenosis. Adults already receiving beta-blockers be assigned randomly in 1:1 ratio to either continue or withdraw the beta-blockers medication at least 72 hours before and at least 7 days after TAVI. The primary endpoint is permanent pacemaker implantation rates in 7 days after the procedure. Secondary endpoints include death, cardiogenic shock and arrhythmias/conduction abmormalities with time frame 12 months.
Trial Details
NCT Number NCT05721170
Lead Sponsor National and Kapodistrian University of Athens
Conditions Aortic Valve Stenosis
Enrollment 347 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov