Clinical trial NCT04408716: Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings
Official title: Risk of Asymptomatic Cerebral Embolism During Atrial Fibrillation Ablation Using Smart Touch SF Catheter With Ablation Index Guided High-power Short-duration Strategy Versus Smart Touch Catheter With Standard Settings Evaluated by High-resolution Diffusion-weighted Magnetic Resonance Imaging Technique (REDUCE-IT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Asymptomatic Cerebral Embolism
radiofrequency ablation
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients≥18 years of age prior to obtaining the written informed consent.
2. Patients with electrocardiographically documented, symptomatic atrial fibrillation.
3. Patients is scheduled to undergo circumferential pulmonary vein antrum radiofrequency ablation.
4. Patient or patient's legal representative is able and willing to give informed consent.

Exclusion Criteria:

1. Moderate to severe valvular heart disease.
2. Contraindication for anticoagulation therapy.
3. Contraindication for Diffusion-Weighted MRI.
4. Ischemic stroke or transient ischemic attack within 6 months prior to the consent date.
5. Acute coronary syndrome within 3 months prior to the consent date.
6. Prior left atrial appendage occlusion device.
7. Prior septal occlusion device.
8. Left atrial size greater than 55 mm.
9. Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion).
10. Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study.
11. Simultaneous participation in another study.
12. Unwilling or unable to comply fully with the study procedures and follow-up requirements.

Primary outcomes:
measure: The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.
timeFrame: Within 3 days prior to the ablation；24-72 hours after AF catheter ablation procedure.
Secondary outcomes:
measure: Cognitive functional status evaluated using the Montreal Cognitive Assessment (MoCA) test.
timeFrame: On the 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.
measure: Overall complication rate during catheter ablation and up to 3 months follow up.
timeFrame: 3 months after the catheter ablation procedure.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affilliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
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