Actively Recruiting
Grid eXplore Mapping Study
Led by Abbott Medical Devices · Updated on 2026-05-06
200
Participants Needed
5
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Grid eXplore Mapping Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must provide written informed consent before any study procedures
- Subject is at least 18 years old
- Documented symptomatic paroxysmal atrial fibrillation with physician's note indicating self-terminating AF and electrocardiographically documented AF (12-lead ECG or at least 30 seconds on another ECG device)
- Subject plans to undergo cardiac electroanatomic mapping and ablation to treat paroxysmal AF
- Able and willing to comply with all study requirements including pre-procedure, post-procedure, and follow-up testing and visits
You will not qualify if you...
- Persistent or long-standing persistent atrial fibrillation lasting longer than 1 year
- Known cardiac thrombus present
- Known circumferential pericardial effusion greater than 2 mm before catheter insertion
- Any condition preventing appropriate vascular access
- Implanted intracardiac device within 30 days before procedure
- Pregnant or nursing women
- Ventriculotomy or atriotomy within 28 days before procedure
- Myocardial infarction, acute coronary syndrome, PCI, or valve/coronary bypass surgery within 90 days
- Stroke or transient ischemic attack within 90 days
- History of blood clotting or bleeding disorders
- Unable to receive heparin or acceptable anticoagulation
- Known uncontrolled sensitivity to contrast media
- Previous left atrial surgery including left atrial appendage closure device
- Severe mitral regurgitation by specified measures
- Previous tricuspid or mitral valve replacement or repair
- Presence of prosthetic valves
- Presence of myxoma
- Interatrial baffle or patch present
- Stent, constriction, or stenosis in a pulmonary vein
- Rheumatic heart disease
- Hypertrophic cardiomyopathy
- Active systemic infection
- Severe pulmonary disease or other severe lung/respiratory conditions
- Participation in another clinical trial within 30 days without approval
- Other medical, social, or psychological conditions limiting participation or compliance
- Lack of legal authority
- Unable to read or write
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
3
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
4
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
5
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
Research Team
R
Rio Zhan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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