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Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation With Half-Normal Saline Irrigation for Pulmonary Vein Isolation

Study acronym: Half SALINE-AF
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 14, 2026 → Dec 14, 2026
See other at-risk trials from First Affiliated Hospital of Ningbo University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 14, 2026 to Dec 14, 2026
    • Study completion pushed from Sep 14, 2026 to Feb 25, 2027
    • Eligibility criteria shortened, about 2 words
    • Study title shortened, about 3 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary Objective: To evaluate the efficacy of the Very High Power Short Duration (vHPSD) ablation mode with half-normal saline irrigation in achieving pulmonary vein isolation (PVI) for atrial fibrillation, by comparing the single-procedure acute pulmonary vein isolation success rate. Secondary Objective: To assess the safety of the vHPSD ablation mode with half-normal saline irrigation in PVI for atrial fibrillation, by comparing the incidence of steam pops (POPs). Study Significance This study aims to address the current limitation of insufficient lesion formation in the anterior left atrial wall when using a uniform 90W/4s ablation strategy with normal saline irrigation. By segmenting the left atrium, different irrigation protocols will be applied: 90W/4s ablation with normal saline irrigation will be performed in the posterior area of left atrium, while 90W/4s ablation with half-normal saline irrigation will be performed in the anterior area of left atrium. This approach is anticipated to enhance the procedural immediate success rate (measured by the rate of acute, first-pass PVI), improve overall procedural efficiency, and ensure procedural safety.
Trial Details
NCT Number NCT07835126
Lead Sponsor First Affiliated Hospital of Ningbo University
Conditions
(from sponsor)		 Paroxysmal Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov