Paroxysmal Atrial Fibrillation (PAF)NCT07421076
Grid eXplore Mapping Study
A study testing Grid X and EnSite X v3.1.1 Software in people with Paroxysmal Atrial Fibrillation (PAF), run by Abbott Medical Devices at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- Grid X and EnSite X v3.1.1 Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 2 Apr 2026to 31 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Patients with prosthetic valves
- Patients with a myxoma
- Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
- Stent, constriction, or stenosis in a pulmonary vein
- Rheumatic heart disease
- Hypertrophic cardiomyopathy
- Active systemic infection
- 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
- 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
- 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.
- Individuals without legal authority
- Individuals unable to read or write
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Secretary of GCP Office, +86-10-64456966, office@anzhengcp.com
Song Zuo
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Secretary of GCP Office, +86-28-85422707, huaxigcp@163.com
Kaijun Cui
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Secretary of GCP Office, +86-571-86960497, xyc@srrsh.com
Chenyang Jiang
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Secretary of GCP Office, +86-531-82165414, qlyygcp_ms@qiluhospital.com
Kai Zhang
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Secretary of GCP Office, +86-574-87085146, dyyygcp@163.com
Huimin Chu
About this 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.
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.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- Grid X and EnSite X v3.1.1 Software
- Keywords
- Paroxysmal atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grid X and EnSite X v3.1.1 SoftwareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Grid X and EnSite X v3.1.1 Software | Experimental | Not described Receives: Device: Grid X and EnSite X v3.1.1 Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: During the study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start2 Apr 2026
- Primary completion7 Nov 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amber Miller, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421076
- Sponsor's protocol ID
- ABT-CIP-10585
- Other IDs
- CRD_1099
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No