NCT07036965

Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Hangzhou Dinova EP Technology Co., Ltd · Industry
• Sex: All
• Age: 118 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DEVICE	CardiPulse	abc
DEVICE	FaraPulse	bcd

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-07-30
• Completion: 2031-06-30
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: China