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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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).
The Second Affilliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.
The brain hDWI should be performed within 3 days prior to the ablation procedure to investigate previous cerebral lesions and reevaluated within 24-72 hours post ablation to determine the occurrence of new asymptomatic cerebral embolic lesions. The acute cerebral embolic lesion is typically defined as a new focal hyper-intense area detected on the diffusion-weighted sequence, and a hyper-intense signal intensity in the fluid-attenuated inversion recovery sequence, and meantime confirmed by apparent diffusion coefficient mapping as corresponding area of restricted diffusion to rule out a shine-through artifact.
Time frame: Within 3 days prior to the ablation；24-72 hours after AF catheter ablation procedure.
Cognitive functional status evaluated using the Montreal Cognitive Assessment (MoCA) test.
The Montreal Cognitive Assessment (MoCA) is known as a brief cognitive screening tool with a high sensitivity and specificity for detecting a mild cognitive impairment. All enrolled patients undergo a prospective assessment of their cognitive function using the MoCA test at 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.
Time frame: On the 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.
Overall complication rate during catheter ablation and up to 3 months follow up.
Overall complication rate after catheter ablation of AF.
Time frame: 3 months after the catheter ablation procedure.
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