Compares two pulsed field ablation catheters for treating atrial fibrillation
Tests two heart-rhythm catheters in people with atrial fibrillation, an irregular heartbeat.
Plain-language title generated from the registry record
Registry title: Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
Key facts
- Where
- Hangzhou, ChinaSee the site
Where in China
- Ningbo First HospitalHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou Dinova EP Technology Co., Ltd
- Trial code
- NCT07036965
- Record updated
- 25 June 2025
- Original description
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.Read full original descriptionShow less
Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial
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.
Inclusion: Older than 18 years; Diagnosed with drug-refractory, symptomatic atrial fibrillation; The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2); Have a situation of:; requires oral anticoagulation therapy; high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy; 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: Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment; Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment; History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery; Current or anticipated participation in other drug or device clinical trials; History of persistent atrial fibrillation >1 year; Atrial fibrillation was secondary to thyroid disease or other reversible reasons; Rheumatic heart disease; Unstable angina; Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding; Active systemic infection; Life expectancy <12 months (e.g., advanced malignancy); Any other condition or abnormality deemed by the investigator to warrant exclusion; Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV; Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis; Left atrial anteroposterior diameter >50 mm; Evidence of left atrial or left atrial appendage thrombus on imaging examination; Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings; Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation; Pregnancy or breastfeeding.