New heart mapping tech could improve AFib treatment safety
NCT ID NCT07421076
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a new mapping catheter and software to help doctors treat atrial fibrillation, a common heart rhythm problem. About 200 Chinese patients will receive a standard ablation procedure, but doctors will use the new tools to guide them. The goal is to see if the new devices are safe and effective at identifying problem areas in the heart.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Grid X Mapping Catheter and EnSite X Software (device)
- What this could lead to
- If successful, this could provide a safer and more effective way to map and treat atrial fibrillation, potentially improving outcomes for patients.
- What could go wrong
- This is an early-stage study with only 200 participants, so results may not apply to everyone. There are risks like heart damage or stroke from the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Oct 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Paroxysmal atrial fibrillation (PAF) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Beijing Anzhen Hospital, Capital Medical University
RECRUITINGBeijing, China
-
Qilu Hospital of Shandong University
RECRUITINGJinan, Shandong, China
-
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, China
-
The First Affiliated Hospital of Ningbo University
RECRUITINGNingbo, Zhejiang, China
-
West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new mapping and ablation system fix recurring atrial fibrillation?
- Can a new catheter zap away irregular heartbeats?
- Which imaging guide leads to better outcomes in heart ablation?
- Ablation without X-Rays: a new way to fix irregular heartbeats?
- Smart pacemaker aims to catch and stop heart flutter before it starts
- New heart zapping technique could free patients from irregular rhythm