Heart Mapping Catheter and Software for Paroxysmal Atrial Fibrillation in China
Tests a mapping catheter and software during heart rhythm treatment in Chinese adults.
Plain-language title generated from the registry record
Registry title: Grid eXplore Mapping Study
Key facts
- Where
- Beijing, Chengdu, Hangzhou, Jinan, and Ningbo, ChinaSee the 5 sites
Where in China
- Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Abbott Medical Devices
- Trial code
- NCT07421076
- Record updated
- 1 July 2026
- Original description
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.Read full original descriptionShow less
Grid eXplore Mapping Study
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.
Inclusion: Subject must provide written informed consent prior to any clinical investigation-related procedure; Subject is at least 18 years of age; Documented symptomatic paroxysmal AF, defined as:; Physician's note indicating self-terminating AF AND; Electrocardiographically documented AF NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device; Subject plans to undergo a cardiac electroanatomic mapping and ablation procedure to treat their paroxysmal AF; Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements.
Exclusion: Known existing circumferential pericardial effusion >2 mm prior to catheter insertion; Implanted intracardiac device within 30 days prior to the procedure; Patients who have had a ventriculotomy or atriotomy within 28 days prior to the procedure; Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication; Previous left atrial surgical procedure (including left atrial appendage (LAA) closure device); Previous tricuspid or mitral valve replacement or repair; Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor; Known presence of cardiac thrombus; Presence of any condition that precludes appropriate vascular access; Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days; Stroke or TIA (transient ischemic attack) within the last 90 days; History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state; Rheumatic heart disease; Active systemic infection; Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms; Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results; Primary diagnosis or indication for treatment of persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration); Pregnant or nursing; Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation; Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2); Patients with prosthetic valves; Patients with a myxoma; Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt; Stent, constriction, or stenosis in a pulmonary vein; Hypertrophic cardiomyopathy; Individuals without legal authority; Individuals unable to read or write.