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Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Study acronym: SCORE
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 14, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 1, 2024 to Sep 30, 2025
    • Start date changed from estimate of Dec 1, 2023 to Mar 17, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 1, 2023 to Dec 1, 2023
    • Study sites: 0 to 1
    • Primary completion date: Sep 30, 2024 to Dec 1, 2024
    v3
  3. Start date: Jul 1, 2023 to Oct 1, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) has limited success. The superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein triggers for PAF. It is estimated that SVC isolation (SVCI) could improve the clinical results for patients with PAF. However, results from previous studies about SVCI remain controversial. It is possible that safety concerns for SVCI outweigh its benefits and lead to inadequate ablation. To address this issue, the introduction of a quantitative ablation index (AI) for SVCI may provide a solution. The goal of this prospective, randomized controlled trial is to test the efficacy and safety of quantitative SVCI in addition to PVI in PAF. Participants with PAF will be randomly assigned to either PVI group or PVI+ quantitative SVCI group in a 1:1 ratio and will be followed up for 12 months. The main questions it aims to answer are: 1. Evaluate the efficacy of PVI+SVCI guided by quantitative AI. 2. Assess the safety of PVI+SVCI guided by quantitative AI. The primary end point is treatment success at 3 months after the index ablation. The secondary end points include treatment success at 12 months, and safety outcomes.
Trial Details
NCT Number NCT05908955
Lead Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov