Grid eXplore Mapping Study

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.

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.

Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation-related procedure.

2. Subject is at least 18 years of age.

3. 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.

4. Subject plans to undergo a cardiac electroanatomic mapping and ablation procedure to treat their paroxysmal AF.

5. Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements

Exclusion Criteria:

1. Primary diagnosis or indication for treatment of persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
2. Known presence of cardiac thrombus.
3. Known existing circumferential pericardial effusion >2 mm prior to catheter insertion.
4. Presence of any condition that precludes appropriate vascular access
5. Implanted intracardiac device within 30 days prior to the procedure
6. Pregnant or nursing
7. Patients who have had a ventriculotomy or atriotomy within 28 days prior to the procedure
8. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
9. Stroke or TIA (transient ischemic attack) within the last 90 days
10. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
11. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
12. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
13. Previous left atrial surgical procedure (including left atrial appendage (LAA) closure device)
14. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
15. Previous tricuspid or mitral valve replacement or repair
16. Patients with prosthetic valves
17. Patients with a myxoma
18. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
19. Stent, constriction, or stenosis in a pulmonary vein
20. Rheumatic heart disease
21. Hypertrophic cardiomyopathy
22. Active systemic infection
23. 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
24. 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
25. 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.
26. Individuals without legal authority
27. Individuals unable to read or write