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

Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial

This will try two different pulsed-field ablation catheters in people with symptomatic, drug-refractory atrial fibrillation who also need left atrial appendage closure to see which is safer and more effective.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 292 (estimated)
• Ages: 118 Years and up
• Sex: All
• Sponsor: Hangzhou Dinova EP Technology Co., Ltd (Industry-sponsored)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07036965 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 with symptomatic, drug-refractory AF, CHA2DS2-VA score ≥ 2, and either a need for anticoagulation or high bleeding risk (HAS-BLED ≥ 3) who are candidates for combined PFA and LAAC are ideal candidates.

Not a fit: Patients with persistent AF longer than 1 year, AF due to reversible causes, left atrial diameter >50 mm, or imaging evidence of left atrial/LAA thrombus are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, the comparison could identify the safer and more effective PFA catheter and improve combined AF ablation plus LAAC outcomes while reducing complications like arcing and tissue edema.

How similar studies have performed: Small prior reports have shown that combined PFA and LAAC can be feasible and appear safe with few reports of edema, but no large-scale trials have directly compared different PFA systems.

Eligibility criteria

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 this trial is running

Hangzhou

• Ningbo First Hospital — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Huimin Chu, Dorctor

Conditions Atrial Fibrillation; atrial fibrillation; pulsed field ablation; LAAC