Grid eXplore Mapping Study

NCT07421076 | Recruiting FDA Device

• 2 other identifiers: ABT-CIP-10585CRD_1099
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Keywords

Paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Grid X and EnSite X v3.1.1 Software

EXPERIMENTAL

Device: Grid X and EnSite X v3.1.1 Software

Interventions

Grid X and EnSite X v3.1.1 Software DEVICE

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.

Grid X and EnSite X v3.1.1 Software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide written informed consent prior to any clinical investigation-related procedure.
• Subject is at least 18 years of age.
• 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.
• Subject plans to undergo a cardiac electroanatomic mapping and ablation procedure to treat their paroxysmal AF.
• Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements

You may not qualify if:

• Primary diagnosis or indication for treatment of persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
• Known presence of cardiac thrombus.
• Known existing circumferential pericardial effusion \>2 mm prior to catheter insertion.
• Presence of any condition that precludes appropriate vascular access
• Implanted intracardiac device within 30 days prior to the procedure
• Pregnant or nursing
• Patients who have had a ventriculotomy or atriotomy within 28 days prior to the procedure
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
• Stroke or TIA (transient ischemic attack) within the last 90 days
• History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
• Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• Previous left atrial surgical procedure (including left atrial appendage (LAA) closure device)
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
• Previous tricuspid or mitral valve replacement or repair

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

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

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amber Miller

  Abbott

  STUDY DIRECTOR

Central Study Contacts

Rio Zhan

CONTACT

+86-21-2320 4181; wanlei.zhan@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): November 7, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)