| NCT ID | NCT07421076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Paroxysmal Atrial Fibrillation (PAF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-02 |
| Primary Completion | 2026-11-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-04-02 with a primary completion date of 2026-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Amber Miller
STUDY DIRECTOR
Abbott
Frequently Asked Questions
Who can join the NCT07421076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paroxysmal Atrial Fibrillation (PAF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07421076 currently recruiting?
Yes, NCT07421076 is actively recruiting participants. Contact the research team at wanlei.zhan@abbott.com for enrollment information.
Where is the NCT07421076 trial being conducted?
This trial is being conducted at Jinan, China, Chengdu, China, Hangzhou, China, Ningbo, China and 1 additional location.
Who is sponsoring the NCT07421076 clinical trial?
NCT07421076 is sponsored by Abbott Medical Devices. The principal investigator is Amber Miller at Abbott. The trial plans to enroll 200 participants.
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