Actively Recruiting
Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
Led by Hangzhou Dinova EP Technology Co., Ltd · Updated on 2025-06-25
292
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 18 years
- Diagnosed with drug-refractory, symptomatic atrial fibrillation
- High risk of stroke with CHA2DS2-VA score of 2 or more
- Requires oral anticoagulation therapy or has high bleeding risk (HAS-BLED score 3 or higher) and is unsuitable or unwilling for long-term anticoagulation
- Able to understand the study, voluntarily agree to participate, sign informed consent, and complete follow-up as required
You will not qualify if you...
- History of persistent atrial fibrillation longer than 1 year
- Atrial fibrillation caused by thyroid disease or other reversible conditions
- Left atrial anteroposterior diameter greater than 50 mm
- Presence of left atrial or left atrial appendage blood clots on imaging
- Other arrhythmias requiring catheter ablation prior to enrollment
- Rheumatic heart disease
- Left ventricular ejection fraction below 40% or NYHA class III/IV heart failure
- Unstable angina
- Heart attack or heart surgery within 3 months before enrollment
- Prior left atrial appendage closure or related heart surgeries
- Mechanical mitral valve prosthesis or metallic annuloplasty rings implanted
- Intracardiac thrombus or other abnormalities preventing catheter use
- Contraindications to anticoagulation or bleeding disorders
- Active systemic infection
- Severe kidney impairment or dialysis history
- Pregnancy or breastfeeding
- Life expectancy less than 12 months
- Current or planned participation in other drug or device trials
- Any other condition deemed exclusionary by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ningbo First Hospital
Hangzhou, China
Actively Recruiting
Research Team
H
Huimin Chu, Dorctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here