Actively Recruiting
FIH Study of PFLotus in Persistent Atrial Fibrillation
Led by The Third People's Hospital of Chengdu · Updated on 2025-12-24
40
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation. The goal of this clinical trial is to evaluate the safety and effectiveness of a novel, PFA catheter that transitions between large 'petals' (single-shot), and a small, spherical 'bud' (large-focal/linear), enabling a PVI-plus strategy in patients with persistent AF (PersAF). The main questions it aims to answer are: 1. Is there an absence of serious procedure or device-related adverse events within 7 days? 2. Can the catheter achieve durable lesions? This trial enrolled patients with perAF , who were treated under general anesthesia with the shape-adaptive PFA catheter (PFLotus, bipolar, biphasic, 850 V, 60 μs, EnChannel Medical). Participants will: 1. Undergo PVI and linear ablation with the PFLotus PFA catheter under general anesthesia; 2. Undergo remapping within 3-month post the index ablation to assess the durability of the lesions; 3. Undergo follow-up occurred at 7 days, 30 days, 3, 6, and 12 months. Recurrence was assessed via 12-lead ECG at each visit and 24-hour or 7-day Holter monitoring at 6 and 12 months.
CONDITIONS
Official Title
FIH Study of PFLotus in Persistent Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years (inclusive), regardless of gender
- Diagnosed with symptomatic persistent atrial fibrillation lasting more than 7 days or documented by ECG/Holter within the past year
- Poor response or intolerance to at least one class I or class III antiarrhythmic drug
- Willing to participate in the trial, comply with follow-up visits, and provide informed consent
You will not qualify if you...
- Diagnosis of paroxysmal atrial fibrillation
- Atrial fibrillation caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac causes
- Undergoing retreatment after ablation for rapid atrial tachyarrhythmias
- Sustained ventricular tachycardia or ventricular fibrillation
- Left atrial diameter greater than 55 mm
- Pulmonary vein stenosis over 70% or prior pulmonary vein stent implantation
- History of left atrial ablation or cardiac surgery including left atrial appendage closure
- Implanted permanent pacemaker, biventricular pacemaker, loop recorder, or implantable cardioverter-defibrillator
- Contraindications to anticoagulation or history of coagulation or bleeding abnormalities
- Severe pulmonary disease including severe pulmonary arterial hypertension or severe dyspnea with blood gas abnormalities
- Prosthetic heart valve, severe heart failure (NYHA Class III or IV), or left ventricular ejection fraction below 40%
- Closure of atrial or ventricular septal defects
- Atrial myxoma or left atrial appendage device implantation
- History within 3 months of myocardial infarction, unstable angina, percutaneous coronary intervention, cardiac surgery, heart failure hospitalization, or pericarditis
- History within 3 months of cerebral infarction, transient ischemic attack, or documented thromboembolic events
- History of malignant tumor or life expectancy under 12 months
- Mental disorders or inability to cooperate
- Lactating, pregnant, or planning pregnancy
- Acute or severe systemic infection or significant liver/renal abnormalities
- Participation in other interventional clinical trials or judged ineligible by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Third People's Hospital of Chengdu
Chengdu, China
Actively Recruiting
Research Team
S
Shiqiang Xiong, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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