Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation

NCT07036965 | Recruiting

• 1 other identifier: CP-IIS-007
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation; pulsed field ablation; LAAC

Outcome Measures

Primary Outcomes (1)

• 12-month atrial fibrillation (AF) ablation success rate

  Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)

  12 months post-procedure

Secondary Outcomes (10)

• Acute pulmonary vein ablation success rate

  Immediately post-procedure

• Incidence of major adverse events (MAEs) related to the device

  Within 7 days post-procedure

• Incidence of repeat ablation

  Within 12 months post-procedure

• AF burden

  6 and 12 months post-procedure

• Incidence of cardiovascular MAEs

  Within 12 months post-procedure

Study Arms (2)

CardiPulse Group

EXPERIMENTAL

Patients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter

Device: CardiPulse

FaraPulse Group

ACTIVE COMPARATOR

Patients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter

Device: FaraPulse

Interventions

CardiPulse DEVICE

abc

CardiPulse Group

FaraPulse DEVICE

bcd

FaraPulse Group

Eligibility Criteria

• Age: 118 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Dinova EP Technology Co., Ltd: lead

Study Sites (1)

Ningbo First Hospital

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Huimin Chu, Dorctor

CONTACT

+86 574-87085211; epnbheart@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): June 30, 2031
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)