Grid X mapping for paroxysmal atrial fibrillation
Official title: Grid eXplore Mapping Study
Run by Abbott Medical Devices · NCT07421076 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 5 sites (Jinan, Shandong and 4 other locations) |
| Status | Recruiting |
| Started | April 2, 2026 |
| Main results expected | November 7, 2026 |
| Study ends | October 31, 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07421076 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting -
West China Hospital of Sichuan University
Chengdu, Sichuan, China 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 Recruiting
Study contacts
- Study coordinator: Rio Zhan
- Email: wanlei.zhan@abbott.com
- Phone: +86-21-2320 4181
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Intracardiac Echocardiography-guided vs mapping-guided pulsed-field ablation for paroxysmal atrial fibrillation
This trial will test whether using intracardiac echocardiography (ICE) guidance is as safe and effective as three-dimensional mapping guidance for pulsed-field ablation in people with paroxysmal atrial fibrillation undergoing ablation.
-
FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation
This trial tests the FARAFLEX Mapping and PFA System to see if it can safely help adults with drug-refractory paroxysmal or persistent atrial fibrillation.
-
Redo AF ablation using the Sphere-9 catheter and Affera system for recurrent paroxysmal and persistent atrial fibrillation
The study will try the Sphere-9 catheter with the Affera ablation and mapping systems for adults who have symptomatic recurrent paroxysmal or persistent atrial fibrillation after one prior ablation.
-
Pulmonary vein isolation plus box isolation of fibrotic areas using the Globe pulsed field system for symptomatic paroxysmal or persistent atrial fibrillation
This trial will test whether using the Globe pulsed field system to perform pulmonary vein isolation plus box isolation of fibrotic areas helps people with symptomatic paroxysmal or persistent atrial fibrillation stay free of arrhythmia over 12 months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.