Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings

Chongqing Medical University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Ablation Index Guided High-Power Short-Duration Strategy; Procedure: Standard Radiofrequency Ablation Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04408716

REDUCE-IT Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Ablation Index Guided High-Power Short-Duration Group

Experimental group

Description:

For patients assigned to undergo AF ablation with ablation index guided high-power short-duration strategy, 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).

Treatment:

Procedure: Ablation Index Guided High-Power Short-Duration Strategy

Standard Radiofrequency Ablation Group

Active Comparator group

Description:

For patients assigned to undergo AF ablation with standard radiofrequency ablation group, 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).

Treatment:

Procedure: Standard Radiofrequency Ablation Technique