RecruitingNot ApplicableNCT07301190

FIH Study of PFLotus in Persistent Atrial Fibrillation

First-in-Human Experience Using a Novel Shape-Adaptive Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation

Sponsor

The Third People's Hospital of Chengdu

Enrollment

40 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Persistent Atrial Fibrillation

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of a new drug called PFLotus for people with persistent atrial fibrillation — an irregular heart rhythm that has lasted more than 7 days. The study is in its earliest phase, primarily looking at safety, tolerability, and finding the right dose. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with symptomatic persistent atrial fibrillation (AF lasting more than 7 days) - Your AF has been documented on an ECG or heart monitor recording - You meet specific heart rate and rhythm criteria at screening **You may NOT be eligible if...** - You have certain other types of heart problems (such as heart failure with very low pumping function, or certain valve conditions) - You have had a stroke or blood clot recently - You are on certain medications that may interact with the study drug - You are pregnant or breastfeeding - You have significant kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulse field ablation with the PFLotus catheter

PVI was performed in all patients. Additional linear ablation strategies Including the left atrial posterior wall (LAPW), mitral isthmus (MI), or cavotricuspid isthmus (CTI), were performed at the operator's discretion.