Comparing two pulsed-field ablation catheters for atrial fibrillation with left atrial appendage closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with symptomatic, drug-refractory AF and elevated stroke risk will undergo pulsed-field ablation using either the CardiPulse or FaraPulse catheter combined with left atrial appendage closure following an "ablation-first" approach. The protocol tracks procedural success (pulmonary vein isolation and LAAC implantation) and safety outcomes, with special attention to arcing when metallic implants are present and to post-ablation tissue edema. Device-specific parameters (voltage, pulse width, number of cycles) will be recorded to compare lesion depth and area between systems. Participants will have clinical and imaging follow-up to capture AF recurrence, device performance, and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Older than 18 years.
2. Diagnosed with drug-refractory, symptomatic atrial fibrillation.
3. The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
4. Have a situation of:

   1. requires oral anticoagulation therapy
   2. high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy.
5. Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion Criteria:

1. History of persistent atrial fibrillation \>1 year.
2. Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
3. Left atrial anteroposterior diameter \>50 mm.
4. Evidence of left atrial or left atrial appendage thrombus on imaging examination.
5. Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.
6. Rheumatic heart disease.
7. Left ventricular ejection fraction \<40% or New York Heart Association (NYHA) class III/IV.
8. Unstable angina.
9. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
10. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
11. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
12. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
13. Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
14. Active systemic infection.
15. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or history of renal dialysis.
16. Pregnancy or breastfeeding.
17. Life expectancy \<12 months (e.g., advanced malignancy).
18. Current or anticipated participation in other drug or device clinical trials.
19. Any other condition or abnormality deemed by the investigator to warrant exclusion.

Where it's running

• Ningbo First Hospital
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Huimin Chu, Dorctor
• Email: epnbheart@163.com
• Phone: +86 574-87085211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.