FIH Study of PFLotus in Persistent Atrial Fibrillation (NCT07301190) | Clinical Trial Compass
RecruitingNot Applicable
FIH Study of PFLotus in Persistent Atrial Fibrillation
China40 participantsStarted 2025-06-11
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
✓. Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF.
Exclusion criteria
✕. Paroxysmal atrial fibrillation (AF)
✕. AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
✕. Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
✕. Patients with sustained ventricular tachycardia or ventricular fibrillation
✕. Left atrial anteroposterior diameter \> 55 mm
. Implantation of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function)