FIH Study of PFLotus in Persistent Atrial Fibrillation
ConditionPersistent Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Third People's Hospital of Chengdu
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Pulse field ablation with the PFLotus catheter
DevicePVI 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Ablation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The primary safety endpoint
The primary safety endpoint was the incidence of primary adverse events (PAEs) within 7 days post-ablation. Later-occurring events (device/procedure-related death, atrio-esophageal fistula, PV stenosis) were also classified as PAEs. Persistent diaphragmatic paralysis or phrenic nerve palsy at 3 months were considered PAEs.
Time frame
Seven days post index ablation procedure2
The primary efficacy endpoint
The primary efficacy endpoint was acute procedural success, defined as the proportion of patients achieving: 1) complete electrical isolation of all PVs, and 2) for those undergoing linear ablation, confirmed bidirectional block at all targeted sites (LAPW, MI, CTI).
Time frame
Immediately after the index ablation procedureSecondary outcomes
1
Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint]
The outcome is defined as the proportion of participants who achieve complete electrical isolation of all targeted pulmonary veins immediately after the index ablation procedure.
Time frame
Immediate after the index ablation procedure2
Acute Bidirectional Block Success Rate for Each Targeted Linear Ablation Site [Secondary Efficacy Endpoint]
The outcome is defined as the proportion of each targeted linear ablation site (e.g., left atrial posterior wall \[LAPW\], mitral isthmus \[MI\], cavotricuspid isthmus \[CTI\], superior vena cava \[SVC\]) that achieves verified bidirectional block immediately after the index ablation procedure. Each linear site is assessed independently, and the success rate for each site is reported separately.
Time frame
Immediate after the index ablation procedure3
Durable Bidirectional Block Success Rate for Each Targeted Linear Ablation Site at 3-Month Remapping [Secondary Efficacy Endpoint]
The outcome is defined as the proportion of each targeted linear ablation site (LAPW, MI, CTI, SVC) that maintains verified bidirectional block (without recurrence of conduction) at 3-month remapping after the index ablation procedure. Each linear site is assessed independently, and the durable success rate for each site is reported separately.
Time frame
3 months after the index ablation procedure4
1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint]
The outcome is defined as the proportion of participants who remain free from recurrent atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, atrial tachycardia) within 1 year after the index ablation procedure. Recurrence is defined as any episode of atrial tachyarrhythmia lasting ≥30 seconds, confirmed by 12-lead electrocardiogram or 72-hour Holter monitoring, following the 3-month blanking period.
Time frame
1 year after the index ablation procedureSponsors and contacts
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Source ClinicalTrials.gov