Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications

Not Applicable

Not yet recruiting

• Conditions: Ventricular Tachycardia (VT); Atrial Tachycardia; Typical Atrial Flutter; Paroxysmal Atrial Fibrillation (PAF)

• Registration Number: NCT07079813
• Lead Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.

Brief Summary

The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias.

Detailed Description

The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias. In addition, the study assessed the catheter's usability and mapping performance through postoperative physician feedback.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-07-14
• Study First Posted: 2025-07-23
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-31
• Study Start: 2025-08-30
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
primary efficacy endpoint	On the day of the surgery	The proportion of immediate success (all participating subjects) in treating rapid arrhythmias using EasyStars™ High Density Mapping Catheter in combination with cardiac ablation catheters and three-dimensional cardiac electrophysiology mapping systems