Grid X mapping for paroxysmal atrial fibrillation

Grid eXplore Mapping Study

This study will try the Grid X catheter together with the EnSite X mapping system during catheter ablation to see if it helps Chinese adults with paroxysmal atrial fibrillation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abbott Medical Devices (industry)
• Locations: 5 sites (Jinan, Shandong and 4 other locations)
• Trial ID: NCT07421076 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, multicenter, pre-NMPA approval study enrolling up to 200 adults with symptomatic paroxysmal atrial fibrillation. Participants will undergo catheter mapping and ablation using the Advisor HD Grid X Mapping Catheter with the EnSite X EP System v3.1.1 to create atrial geometries and voltage maps. Safety and effectiveness will be tracked through follow-up visits at 7 days and at 3, 6, and 12 months after the procedure. The trial aims to confirm device performance and capture procedure-related adverse events in a Chinese patient population.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) in China with symptomatic, documented paroxysmal atrial fibrillation who plan to undergo electroanatomic mapping and catheter ablation and can complete post-procedure follow-up.

Not a fit: Patients with persistent or long-standing persistent AF, known cardiac thrombus, significant pericardial effusion, or those not eligible for ablation are unlikely to benefit from this enrollment.

Why it matters

Potential benefit: If successful, the devices could provide more accurate atrial maps to guide ablation and potentially improve procedural outcomes and safety for patients with paroxysmal AF.

How similar studies have performed: High-density grid catheters and modern electroanatomic mapping systems have shown promise in improving map detail and guiding ablation, though device-specific data for the Grid X with EnSite X v3.1.1 in Chinese PAF patients are limited.

Eligibility criteria

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

Where this trial is running

Jinan, Shandong and 4 other locations

• Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (RECRUITING)
• Beijing Anzhen Hospital, Capital Medical University — Beijing, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Rio Zhan

Conditions: Paroxysmal Atrial Fibrillation, Paroxysmal atrial fibrillation