Grid eXplore Mapping Study
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Rate of specified device and/or procedure-related serious adverse events — From the study procedure to subject's discharge from the hospital
Safety will be summarized as the rate of subjects experiencing a device and/or procedure-related serious adverse event with onset prior to subject discharge from the hospital after any study procedure that used the Grid X mapping catheter and EnSite X EP System (v3.1.1), as defined below: * Esophageal perforating complications * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications / major bleeding event * Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion) - Proportion of subjects with ablation targets identified by HD Grid X catheter — During the study procedure
The primary effectiveness endpoint will be defined as the proportion of subjects in which ablation targets were able to be defined or identified by HD mapping using the Grid X catheter. The definitions of ablation targets include, but are not limited to: * Reconnected pulmonary veins * Low voltage zones * Slow conduction sites * Focal arrhythmias * Complex fractionated electrograms * Areas of fibrosis/scar
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| West China Hospital of Sichuan University | Chengdu | Sichuan | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | Recruiting |
| Beijing Anzhen Hospital, Capital Medical University | Beijing | China | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07421076 on ClinicalTrials.gov ↗ ← All trials in China