Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation

Official title

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

Overview

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.

Interventions

• Device CardiPulse
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• Device FaraPulse
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Primary outcome measures

• 12-month atrial fibrillation (AF) ablation success rate [Time frame: 12 months post-procedure]

Secondary outcome measures (10)

• Acute pulmonary vein ablation success rate [Time frame: Immediately post-procedure]
• Incidence of major adverse events (MAEs) related to the device [Time frame: Within 7 days post-procedure]
• Incidence of repeat ablation [Time frame: Within 12 months post-procedure]
• AF burden [Time frame: 6 and 12 months post-procedure]
• Incidence of cardiovascular MAEs [Time frame: Within 12 months post-procedure]
• Technical success rate of LAAC [Time frame: Immediately post-procedure]
• LAA closure rate [Time frame: 3 and 6 months post-procedure]
• Incidence of new residual shunt [Time frame: 3 and 6 months post-procedure]
• Incidence of device-related thrombus [Time frame: Within 12 months post-procedure.]
• Discontinuation rate of anticoagulants and antiarrhythmic medications [Time frame: Within 12 months post-procedure]

Eligibility criteria

Inclusion criteria

• 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 criteria

• History of persistent atrial fibrillation >1 year.
• Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
• Left atrial anteroposterior diameter >50 mm.
• Evidence of left atrial or left atrial appendage thrombus on imaging examination.
• Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.
• Rheumatic heart disease.
• Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
• Unstable angina.
• 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.
• 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.
• Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
• Active systemic infection.
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
• Pregnancy or breastfeeding.
• Life expectancy <12 months (e.g., advanced malignancy).
• Current or anticipated participation in other drug or device clinical trials.
• Any other condition or abnormality deemed by the investigator to warrant exclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Ningbo First Hospital — Hangzhou

Identifiers

NCT: NCT07036965 · CP-IIS-007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗