An interventional study of Ablation with the PFLotus catheter and Depolar system in Persistent Atrial Fibrillation, sponsored by The Third People's Hospital of Chengdu. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by The Third People's Hospital of Chengdu · Not applicable, Interventional, and Treatment
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:
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:
Background Atrial fibrillation (AF) is the most common persistent cardiac arrhythmia worldwide, affecting an estimated 1.5-2.0% of the general population. As the population ages, the prevalence of AF continues to rise, imposing a substantial and growing burden on healthcare systems. AF significantly impairs quality of life, elevates stroke risk fivefold, triples the incidence of heart failure, and increases overall mortality.
Initial AF management typically involves pharmacotherapy for rate control or rhythm control. Compared to antiarrhythmic drugs (AADs), catheter ablation offers superior efficacy in reducing AF recurrence, lowering cardiovascular hospitalization rates, and preventing arrhythmia relapse. The cornerstone of catheter ablation is pulmonary vein isolation (PVI), which electrically isolates the pulmonary veins from the left atrium. Current guidelines recommend catheter ablation, primarily PVI, for patients with symptomatic, drug-refractory paroxysmal AF, establishing it as a standard therapy for symptomatic paroxysmal or persistent AF.
Pulsed field ablation (PFA) induces cardiomyocyte death via irreversible electroporation using high-voltage, ultra-rapid electric fields. As a non-thermal energy modality, PFA demonstrates selective myocardial tissue affinity. This characteristic may enable durable lesion formation while sparing adjacent critical structures such as the esophagus, blood vessels, pulmonary veins, and phrenic nerve. Notably, PFA has not been associated with thermal energy complications like atrio-esophageal fistula, phrenic nerve palsy, or pulmonary vein stenosis, suggesting the potential for enhanced efficacy with an improved safety profile.
Recent evidence indicates that integrating three-dimensional (3D) mapping and navigation systems into PFA procedures can reduce radiation exposure while improving procedural accuracy and clinical outcomes.
Therefore, this study aims to evaluate the safety and efficacy of PVI, focal, and linear ablation in patients with persistent AF (PersAF) using a novel shape-adaptive PFA catheter (PFLotus, EnChannel Medical) integrated with a new mapping system (DePolar, EnChannel Medical).
Methods Study Population Eligible patients were aged 18-75 years with documented symptomatic persistent AF (duration 7-365 days) who were refractory or intolerant to at least one Class I or III antiarrhythmic drug.
Procedural Workflow All procedures were performed under general anesthesia. Activated clotting time was maintained at ≥300 seconds. An electroanatomic map of the left atrium and pulmonary veins was created using the PFLotus catheter and the DePolar system.
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. For MI ablation, if persistent epicardial connections were identified, adjunctive ablation within the coronary sinus was performed. After a 20-minute waiting period, isolation and block were reassessed.
Follow-up Post-ablation antiarrhythmic drug use was determined by the operator and typically discontinued after three months. Oral anticoagulation was maintained per guidelines. Structured follow-up was conducted at 7 days and 3 months post-ablation, with lesion durability assessed via invasive remapping at 3 months. Additional visits were scheduled at 6 and 12 months. Atrial tachyarrhythmia recurrence was assessed using 12-lead ECGs at each visit and 24-hour or 7-day Holter monitoring at 3, 6, and 12 months.
Endpoints The primary safety endpoint was the incidence of primary adverse events (PAEs) within 7 days post-ablation. Later-occurring events-including device- or procedure-related death, atrio-esophageal fistula, and PV stenosis-were also classified as PAEs. Persistent diaphragmatic paralysis or phrenic nerve palsy at 3 months was considered a PAE.
The primary efficacy endpoint was acute procedural success, defined as the proportion of patients achieving: 1) complete electrical isolation of all pulmonary veins, and 2) confirmed bidirectional block at all targeted linear ablation sites (LAPW, MI, CTI, and SVC) in patients undergoing such ablation.
Secondary efficacy endpoints included:
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 35 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →The Third People's Hospital of Chengdu is the lead sponsor of 12 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. 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:
3. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD).
4. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written .
Exclusion Criteria:
Any of the following cardiac surgeries, implants, or conditions:
History of any of the following within 3 months prior to the procedure:
History of any of the following within 3 months prior to the procedure:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: 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.
Time frame: Immediate after the ablation procedure
Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint]
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 procedure
Acute Bidirectional Block Success Rate for Each Targeted Linear Ablation Site [Secondary Efficacy Endpoint]
Defined as the proportion of each targeted linear ablation site (LAPW, MI, CTI, 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 procedure
Durable Bidirectional Block Success Rate for Each Targeted Linear Ablation Site at 3-Month Remapping [Secondary Efficacy Endpoint]
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 post the index ablation procedure
1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint]
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, after the 3-month blanking period.
Time frame: 1 year post the index ablation procedure
No study locations are listed for this record.
Plan to share: Yes — De-identified IPD to be shared include baseline demographic and clinical data, procedural parameters, safety data (adverse events within 7 days and follow-up), effectiveness data, and post-PFA voltage mapping results. These IPD are all data used in the primary results publication, as sharing them supports reproducible research and advances the understanding of PFLotus PFA Catheters and Depolar mapping system in persistent AF.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 2-year post the primary publication
Access criteria: Eligible Recipients Qualified researchers with academic/institutional affiliation, who submit a feasible research proposal and agree to comply with data protection regulations. 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. Access Process Submit application (proposal, CV, IRB approval, signed DUA) to the corresponding author via designated email.
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