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.

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation (PAF)
• Intervention / Treatment: Device: Grid X and EnSite X v3.1.1 Software

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rio Zhan; Phone Number: +86-21-2320 4181; Email: wanlei.zhan@abbott.com

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Beijing Anzhen Hospital, Capital Medical University
    • Principal Investigator: Song Zuo
    • Contact: Secretary of GCP Office; Phone Number: +86-10-64456966; Email: office@anzhengcp.com
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University
      • Principal Investigator: Kai Zhang
      • Contact: Secretary of GCP Office; Phone Number: +86-531-82165414; Email: qlyygcp_ms@qiluhospital.com
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital of Sichuan University
      • Contact: Secretary of GCP Office; Phone Number: +86-28-85422707; Email: huaxigcp@163.com
      • Principal Investigator: Kaijun Cui
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Principal Investigator: Chenyang Jiang
      • Contact: Secretary of GCP Office; Phone Number: +86-571-86960497; Email: xyc@srrsh.com
    • Ningbo, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
      • Contact: Secretary of GCP Office; Phone Number: +86-574-87085146; Email: dyyygcp@163.com
      • Principal Investigator: Huimin Chu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Grid X and EnSite X v3.1.1 Software

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From the study procedure to subject's discharge from the hospital
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	During the study procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Amber Miller, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2026
• Primary Completion (Estimated): November 7, 2026
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Paroxysmal atrial fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: ABT-CIP-10585; CRD_1099 (Other Identifier: Abbott)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes