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Clinical Trials in China / NCT07036965
Recruiting Not applicable

Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation

NCT07036965 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou Dinova EP Technology Co., Ltd
Phase
Not applicable
Started
2025-06-30
Last updated
2025-06-25

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

CardiPulseFaraPulse

CardiPulse: abc

FaraPulse: bcd

Study summary

Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.

Eligibility

Sex
ALL
Min age
118 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ningbo First Hospital Hangzhou China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07036965 on ClinicalTrials.gov ↗ ← All trials in China