NCT07421076

Grid eXplore Mapping Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to find out if the Grid X Mapping Catheter and EnSite X EP System with EnSite X Software v3.1.1, the devices that are being studied, are safe and effective in treating Chinese patients who have atrial fibrillation. Participants will receive a procedure called catheter mapping and ablation to treat their abnormal heart rhythms and are required to complete 4 follow-up visits at 7 days, 3 months, 6 months and 12 months after the procedure for checkups and tests.

Detailed description

This is a prospective, non-randomized, multicenter, pre-National Medical Products Administration (NMPA) approval study to confirm the safety and effectiveness of the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ when used with EnSite™ X EP System v3.1.1 to create accurate geometries and voltage maps in the atria. A total of up to 200 subjects who have paroxysmal atrial fibrillation will be enrolled in this clinical study.

Conditions

• Paroxysmal Atrial Fibrillation (PAF)

Interventions

Type	Name	Description
DEVICE	Grid X and EnSite X v3.1.1 Software	The study procedure will be performed with the investigational Grid X Mapping Catheter, along with the EnSite X EP System with EnSite X v3.1.1 Software for mapping according to the investigational instructions for use documents. The ablation will be performed with the commercially available TactiFlex Ablation Catheter, Sensor Enabled according to the IFU.

Timeline

• Start date: 2026-04-02
• Primary completion: 2026-11-07
• Completion: 2027-10-31
• First posted: 2026-02-19
• Last updated: 2026-04-09

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated device study