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Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. 2 versions Re-verified since Nov 20, 2023, no change to tracked fieldsv4-v5
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2030
    • Study completion date: Dec 31, 2027 to Dec 31, 2050
    v3
  3. Study description expanded, about 173 words
    • Eligibility criteria shortened, about 4 words
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF
Trial Details
NCT Number NCT03868150
Lead Sponsor Stanford University
Conditions
(from sponsor)		 Postoperative Atrial Fibrillation
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov