Under construction – not a live service
Sign in
Taking people in ChinaNo phase

Compares two pulsed field ablation catheters for treating atrial fibrillation

Tests two heart-rhythm catheters in people with atrial fibrillation, an irregular heartbeat.

Key facts

Who runs it
Hangzhou Dinova EP Technology Co., Ltd
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
Status
Recruiting
People taking part
292 people, planned
Started
30 Jun 2025
Expected to end
30 Jun 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • CardiPulse
  • FaraPulse
Record updated
25 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with atrial fibrillation that medicines have not controlled, who have a high stroke risk. It compares two pulsed field ablation catheters.

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
Atrial fibrillation with symptoms that did not respond to medicines. High stroke risk (CHA2DS2-VA score ≥ 2).
Earlier treatment
Must need oral anticoagulation (blood thinner) therapy, or have a high bleeding risk (HAS-BLED score ≥ 3) and be unable or unwilling to take long-term blood thinners.

Main reasons for not taking part

  • Persistent atrial fibrillation for more than 1 year
  • Left atrial diameter over 50 mm, or a clot in the left atrium or left atrial appendage
  • Left ventricular ejection fraction <40% or NYHA class III/IV heart failure
  • Rheumatic heart disease, or a heart attack, bypass or stent within 3 months
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in China

  • Ningbo First HospitalHangzhou, ChinaContact: Huimin Chu, DorctorTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • CardiPulse GroupTreatment being tested

    Patients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter

    Treatment: CardiPulse

  • FaraPulse GroupExisting treatment, for comparison

    Patients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter

    Treatment: FaraPulse

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Compares two pulsed field ablation catheters for treating atrial fibrillationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 June 2025