Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation (COMBINATION 2P)

Hangzhou DiNovA EP Technology

Status: Enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Device: CardiPulse; Device: FaraPulse

Study type: Interventional

Funder types: Industry

Identifiers

NCT07036965

CP-IIS-007

Details and patient eligibility

About

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.

Enrollment: 292 estimated patients

Sex: All

Ages: 118+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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292 participants in 2 patient groups

CardiPulse Group

Experimental group

Description:

Patients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter

Treatment:

Device: CardiPulse

FaraPulse Group

Active Comparator group

Description:

Patients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter

Treatment:

Device: FaraPulse