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Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 12, 2024 (before its estimated April 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Secondary endpoints: 1 to 5 Study description expanded, about 14 wordsv5 Show 1 more changeShow less
    • Study description expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v4 Show 1 more changeShow less
    • Study sites: 0 to 2
  3. Eligibility criteria expanded, about 11 words Study description expanded, about 61 wordsv3 Show 1 more changeShow less
    • Study description expanded, about 61 words

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 14 words Secondary endpoints: 3 to 1v2 Show 1 more changeShow less
    • Secondary endpoints: 3 to 1

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback. The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method. Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing (RAP) with a common temporary pacemaker lead. This trial is designed to investigate the role and value of RAP after TAVI as a predictor of the necessity of new PPI.
Trial Details
NCT Number NCT06189976
Lead Sponsor National and Kapodistrian University of Athens
Collaborators: Centre Hospitalier Universitaire Saint Pierre
Conditions Aortic Valve Disease, Transcatheter Aortic Valve Implantation, TAVI
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov