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NCT Number: NCT07036965

Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation

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.

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Key information

Age range

118 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CardiPulse

Device

abc

FaraPulse

Device

bcd

Primary outcomes

  1. 12-month atrial fibrillation (AF) ablation success rate

    Time frame: 12 months post-procedure

    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)

Secondary outcomes

  1. Acute pulmonary vein ablation success rate

    Time frame: Immediately post-procedure

    Defined as maintained bidirectional block across the ablation line 20 minutes after ablation

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

    Time frame: Within 7 days post-procedure

    Including stroke/transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve paralysis, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrioesophageal fistula, myocardial infarction, or severe vascular access complications

  3. Incidence of repeat ablation

    Time frame: Within 12 months post-procedure

    Summary ncidence of repeat ablation after the blanking period

  4. AF burden

    Time frame: 6 and 12 months post-procedure

    Record AF burden at 6 and 12 months post-procedure

  5. Incidence of cardiovascular MAEs

    Time frame: Within 12 months post-procedure

    Incidence of thromboembolic events (including stroke/TIA), cardiovascular-related rehospitalization, or cardiovascular mortality within 12 months post-procedure

  6. Technical success rate of LAAC

    Time frame: Immediately post-procedure

    Defined as successful LAA occlusion without residual shunt >3 mm and no device-related complications

  7. LAA closure rate

    Time frame: 3 and 6 months post-procedure

    Defined as imaging-confirmed residual shunt ≤3 mm at the device edges.

  8. Incidence of new residual shunt

    Time frame: 3 and 6 months post-procedure

    Defined as any increase in residual shunt (post-procedure shunt volume - intraoperative shunt volume >0 mm)

  9. Incidence of device-related thrombus

    Time frame: Within 12 months post-procedure.

    Record device-related thrombus events during follow-up

  10. Discontinuation rate of anticoagulants and antiarrhythmic medications

    Time frame: Within 12 months post-procedure

    Record drugs history during follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Huimin Chu, Dorctor

CONTACT

[email protected]

+86 574-87085211

Sponsors and collaborators

Lead sponsor

Hangzhou Dinova EP Technology Co., Ltd

Industry

Registry information

Official study title

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

Acronym: COMBINATION 2P

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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