PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation

NCT07321002 | Not Yet Recruiting

• 1 other identifier: PFLotus with DePolar
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial aims to evaluate the safety and efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field ablation (PFA) catheter (PFLotus, EnChannel Medical) integrated with a novel mapping system (DePolar, EnChannel Medical). The primary study objectives are to determine:

• The incidence of serious procedure- or device-related adverse events within 7 days post-procedure (primary safety endpoint).
• The clinical effectiveness of the integrated PFA and mapping system.
• The ability of the novel PFA system to produce durable ablation lesions. PersAF patients will be treated under general anesthesia using the PFLotus PFA catheter (bipolar, biphasic waveform; 850 V, 60 μs per pulse). Ablation targets, including PVI and other lesions (left atrial posterior wall, mitral isthmus, cavotricuspid isthmus, and superior vena cava), will be accessed under fluoroscopic and DePolar mapping system guidance. Participants will:
• Receive PVI, focal, and linear ablation using the PFLotus PFA catheter and DePolar mapping system under general anesthesia;
• Be monitored for serious procedure- or device-related adverse events during the first 7 days post-procedure;
• Undergo repeat electrophysiological mapping at 3 months to assess lesion durability;
• Attend scheduled follow-up visits at 7 days, 30 days, and 3, 6, and 12 months post-ablation. Atrial arrhythmia recurrence will be assessed via 12-lead electrocardiography at each visit and by 24-hour or 7-day Holter monitoring at the 6- and 12-month visits.

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation; pulse field ablation; pulmonary vein isolaiton; left atrial posterior wall; mitral isthmus isolaiton; cavotricuspid isthmus isolation; superior vena cava; coronary sinus; epicardial ablation

Outcome Measures

Primary Outcomes (2)

• Incidence of Primary Adverse Events (PAEs) Within 3 Months Post-Ablation [Primary Safety Endpoint]

  The primary safety endpoint is defined as the incidence of primary adverse events (PAEs) in patients within 3 months after the index ablation. PAEs include: ① Adverse events occurring within 7 days post-ablation; ② Later-occurring events (device- or procedure-related death, atrio-esophageal fistula, pulmonary vein \[PV\] stenosis); ③ Persistent diaphragmatic paralysis or phrenic nerve palsy at 3 months post-ablation.

  Within 3 months post the index ablation

• Rate of Acute Procedural Success: Complete Pulmonary Vein Isolation and Bidirectional Block at Targeted Linear Ablation Sites [Primary Efficacy Endpoint]

  The primary efficacy endpoint is defined as the rate of acute procedural success immediately after the ablation procedure. Acute procedural success is confirmed when patients meet the following criteria: 1. Complete electrical isolation of all pulmonary veins; 2. Bidirectional block verified at all targeted linear ablation sites (including left atrial posterior wall \[LAPW\], mitral isthmus \[MI\], cavotricuspid isthmus \[CTI\], and superior vena cava \[SVC\]) in those undergoing linear ablation.

  Immediate after the ablation procedure

Secondary Outcomes (4)

• Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint]

  Immediate after the index ablation procedure

• Acute Bidirectional Block Success Rate for Each Targeted Linear Ablation Site [Secondary Efficacy Endpoint]

  Immediate after the index ablation procedure

• Durable Bidirectional Block Success Rate for Each Targeted Linear Ablation Site at 3-Month Remapping [Secondary Efficacy Endpoint]

  3 months post the index ablation procedure

• 1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint]

  1 year post the index ablation procedure

Study Arms (1)

Ablation Group

EXPERIMENTAL

PVI and additional ablation strategies-including ablation of the left atrial posterior wall (LAPW), mitral isthmus (MI), cavotricuspid isthmus (CTI), and superior vena cava (SVC)-were performed in all patients with PerAF.

Device: Ablation with the PFLotus catheter and Depolar system

Interventions

Ablation with the PFLotus catheter and Depolar system DEVICE

PVI and additional ablation strategies-including ablation of the left atrial posterior wall (LAPW), mitral isthmus (MI), cavotricuspid isthmus (CTI), and superior vena cava (SVC)-were performed in all patients with PerAF using the PFLotus PFA catheter and Depolar mapping system.

Ablation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18-75 years (inclusive). 2. Diagnosis of symptomatic persistent atrial fibrillation (AF), defined as documented AF episodes exceeding 7 days or a documented history of persistent AF. Additionally, at least one of the following criteria must be met within 365 days prior to enrollment:
• A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period.
• Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF.
• \. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD).
• \. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written informed consent.

You may not qualify if:

• 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；
• Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation；
• History of left atrial ablation or cardiac surgery (including left atrial appendage closure)；
• 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)；
• Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities；
• Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities；
• Any of the following cardiac surgeries, implants, or conditions:
• Prosthetic heart valve
• NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 40%
• Atrial septal defect or ventricular septal defect closure
• Atrial myxoma, left atrial appendage device implantation or occlusion

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shiqiang Xiong, Doctor of Medicine

CONTACT

8619980510703; xionglliu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 6, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2-year post the primary publication
• Access Criteria: 1. Eligible Recipients Qualified researchers with academic/institutional affiliation, who submit a feasible research proposal and agree to comply with data protection regulations. 2. Accessible Materials De-identified individual participant data (baseline, procedural, follow-up data related to PFA/AF) and supporting documents (study protocol, statistical analysis plan, redacted clinical study report). Identifiable information and raw imaging data are excluded. 3. Access Process Submit application (proposal, CV, IRB approval, signed DUA) to the corresponding author via designated email.