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RecruitingNCT07421076Updated Jul 1, 2026

Grid eXplore Mapping Study

An interventional study of Grid X and EnSite X v3.1.1 Software in Paroxysmal Atrial Fibrillation (PAF), sponsored by Abbott Medical Devices. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

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.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation (PAF)

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Keywords

  • Paroxysmal atrial fibrillation
03

In context

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's planned enrollment of 200 is above the median of 144 across 2,381 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Grid X and EnSite X v3.1.1 Software

    Device: Grid X and EnSite X v3.1.1 Software

Interventions

  • DeviceGrid 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.

06

What researchers measure

Primary outcomes

  1. Rate of specified device and/or procedure-related serious adverse events

    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)

    Time frame: From the study procedure to subject's discharge from the hospital

  2. Proportion of subjects with ablation targets identified by HD Grid X catheter

    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

    Time frame: During the study procedure

07

Study locations

5 of 5 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    Recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan, China
    • Secretary of GCP Office · Contact · huaxigcp@163.com · +86-28-85422707
    • Kaijun Cui · Principal investigator
    Recruiting
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    • Secretary of GCP Office · Contact · xyc@srrsh.com · +86-571-86960497
    • Chenyang Jiang · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Ningbo University
    Ningbo, Zhejiang, China
    • Secretary of GCP Office · Contact · dyyygcp@163.com · +86-574-87085146
    • Huimin Chu · Principal investigator
    Recruiting
  • Beijing Anzhen Hospital, Capital Medical University
    Beijing, China
    • Secretary of GCP Office · Contact · office@anzhengcp.com · +86-10-64456966
    • Song Zuo · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07421076
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Apr 2, 2026
Primary completion
Nov 7, 2026 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

Rio Zhan
Contact
wanlei.zhan@abbott.com
+86-21-2320 4181
Amber Miller
study director · Abbott

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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