NCT05618340

3-Dimensional Mapping System: The PULSTAR Study

Pulsed Field Ablation Paroxysmal Atrial Fibrillation Using a Novel Spiral Catheter Integrated With a 3-Dimensional Mapping System: The PULSTAR Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Shanghai Shangyang Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application. The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter	Routinely placing a coronary sinus electrode catheter, puncturing the interatrial septum, placing one sheath into the left atrium, confirming that the catheter is well in place, and setting the treatment time of the pulse ablation system in advance. Pulmonary vein-by-pulmonary vein ablation using a circular pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation.

Timeline

• Start date: 2022-09-26
• Primary completion: 2024-03-27
• Completion: 2024-06-01
• First posted: 2022-11-16
• Last updated: 2025-07-24

Locations

1 site across 1 country: China