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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
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
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.
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