Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings
Condition: Atrial Fibrillation
MeSH terms: Intracranial Embolism; Atrial Fibrillation; Embolism
Study type: Interventional

Summary: 
      The purpose of this prospective randomized controlled study is to evaluate the risk of
      asymptomatic cerebral embolism during catheter ablation of atrial fibrillation (AF) with
      AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of
      asymptomatic cerebral embolism is determined by brain high-resolution diffusion-weighted
      magnetic resonance imaging technique.
    

Detailed description: 
      Radiofrequency catheter ablation is increasingly performed in patients with paroxysmal and
      persistent atrial fibrillation (AF) in recent decade. However, catheter ablation of AF is
      associated with the occurrence of procedure-related thromboembolic events, especially the
      risk of asymptomatic cerebral embolism detected by brain high-resolution diffusion-weighted
      magnetic resonance imaging (hDWI). Meanwhile, ablation index guided high-power short-duration
      (AI-HPSD) strategy with the advanced SmartTouch SurroundFlow (STSF) catheter is an
      increasingly used technique for catheter ablation of AF, which is proposed to be associated
      with relatively wider and superficial lesions, less risk of esophageal injury, and shorter
      procedure time plus higher rate of first-pass pulmonary vein isolation. Moreover, the
      advanced STSF catheter in AI-HPSD strategy features with the Surround Flow entire tip
      irrigation system, which is a wide-spread distribution of the irrigating solution (56
      irrigation holes), resulting in homogenous cooling and protection from thrombus formation and
      reduced incidence of steam pops. Thus, comparing with the standard radiofrequency ablation
      technique using the SmartTouch (ST) catheter, the AI-HPSD strategy may associate with much
      lower risk of periprocedural asymptomatic cerebral embolism, with the application of advanced
      STSF catheter and shorter procedure time. Therefore, this study is designed as a prospective
      randomized controlled study to evaluate the risk of asymptomatic cerebral embolism during
      catheter ablation of AF with AI-HPSD strategy versus standard radiofrequency ablation
      settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain hDWI.
    

Intervention name(s): Ablation Index Guided High-Power Short-Duration Strategy; Standard Radiofrequency Ablation Technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).; Point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a single center prospective single-blinded randomized controlled trial. Enrolled AF patients planning clinically-indicated catheter ablation is randomly assigned with 1:1 ratio to undergo catheter ablation with ablation index guided high-power short-duration strategy or the standard radiofrequency ablation technique. Besides the evaluation at baseline, all the participants will be followed up at 24-72 hours, 1 month and 3 months post ablation.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Asymptomatic Cerebral Embolism; radiofrequency ablation