First-in-human experience for cardiac arrhythmia mapping using a novel ultra-high-density globe-shaped catheter from...

Area of Science:

• Electrophysiology
• Cardiovascular Medicine
• Medical Devices

Background:

• A novel ultra-high-resolution mapping system, Clarysense, was developed.
• This system features a 100-electrode deflectable, bidirectional, basket-shaped catheter with a central TRUEref electrode.
• It is integrated with the CARTO 3 system for advanced electroanatomic mapping.

Purpose of the Study:

• To evaluate the clinical safety and performance of the new mapping system.
• To assess its utility in mapping complex atrial and ventricular arrhythmias.
• To gather physician feedback on the catheter's performance.

Main Methods:

• A prospective, single-arm, multicenter study was conducted.
• 40 patients undergoing catheter mapping and ablation for arrhythmias were enrolled.
• Mapping was performed using the study catheter, with ablation following the investigator's standard of care.

Main Results:

• The primary effectiveness endpoint (completion of mapping) was achieved in all participants.
• High-quality signals and map resolution were observed during mapping.
• One serious adverse event (transient atrioventricular block) occurred with full recovery. Physician feedback was largely positive regarding signal quality.

Conclusions:

• The novel mapping system offers improved high-density mapping for complex arrhythmias.
• The system provides high-quality signals and excellent map resolution.
• The catheter design and performance exceeded operator expectations in this initial human study.