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Clinical Trial NCT07421076 for Paroxysmal Atrial Fibrillation (PAF) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Grid eXplore Mapping Study 200

Not yet recruiting
Clinical Trial NCT07421076 is an interventional study for Paroxysmal Atrial Fibrillation (PAF) and is currently not yet recruiting. Enrollment is planned to begin on March 31, 2026 and continue until the study accrues 200 participants. Led by Abbott Medical Devices, this study is expected to complete by January 31, 2028. The latest data from ClinicalTrials.gov was last updated on February 19, 2026.
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 mo...

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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 cl...

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Official Title

Grid eXplore Mapping Study

Conditions
Paroxysmal Atrial Fibrillation (PAF)
Other Study IDs
  • ABT-CIP-10585
  • CRD_1099 (Other Identifier) (Abbott)
NCT ID Number
NCT07421076
Start Date (Actual)
2026-03-31
Last Update Posted
2026-02-19
Completion Date (Estimated)
2028-01-31
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Paroxysmal atrial fibrillation
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGrid X and EnSite X v3.1.1 Software
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  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

  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
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Study Central Contact
Contact: Rio Zhan, +86-21-2320 4181, [email protected]
5 Study Locations in 1 Countries

Shandong

Qilu Hospital of Shandong University, Jinan, Shandong, China
Secretary of GCP Office, Contact, +86-531-82165414, [email protected]
Kai Zhang, Principal Investigator

Sichuan

West China Hospital of Sichuan University, Chengdu, Sichuan, China
Secretary of GCP Office, Contact, +86-28-85422707, [email protected]
Kaijun Cui, Principal Investigator

Zhejiang

Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Secretary of GCP Office, Contact, +86-571-86960497, [email protected]
Chenyang Jiang, Principal Investigator
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China
Secretary of GCP Office, Contact, +86-574-87085146, [email protected]
Huimin Chu, Principal Investigator
Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Secretary of GCP Office, Contact, +86-10-64456966, [email protected]
Song Zuo, Principal Investigator