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RECRUITING
NCT07036965
NA

Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation

Sponsor: Hangzhou Dinova EP Technology Co., Ltd

View on ClinicalTrials.gov

Summary

Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.

Official title: Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial

Key Details

Gender

All

Age Range

118 Years - Any

Study Type

INTERVENTIONAL

Enrollment

292

Start Date

2025-06-30

Completion Date

2031-06-30

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

DEVICE

CardiPulse

abc

DEVICE

FaraPulse

bcd

Locations (1)

Ningbo First Hospital

Hangzhou, China