Persistent Atrial FibrillationNCT07321002
PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation
A study testing Ablation with the PFLotus catheter and Depolar system in people with Persistent Atrial Fibrillation, run by The Third People's Hospital of Chengdu.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Ablation with the PFLotus catheter and Depolar system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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 informed consent.
Who cannot join
- 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；
Show all 30Show fewer
- 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
- History of any of the following within 3 months prior to the procedure:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Cardiac surgery (including coronary artery bypass grafting)
- Hospitalization for heart failure
- Pericarditis
- History of any of the following within 3 months prior to the procedure:
- Cerebral infarction or transient ischemic attack (TIA)
- Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography [TEE])
- History of malignant tumor or expected life expectancy < 12 months；
- Mental disorders or history of mental illness with inability to cooperate independently；
- Lactating, pregnant, or women planning or potentially becoming pregnant；
- Acute or severe systemic infection, or significant abnormalities in liver/renal function；
- Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of a Novel Shape-Adaptive Catheter With for Both Single-Shot and Large-Focal Pulsed Field Ablation the DePolar Mapping System in Persistent Atrial Fibrillation
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:
Read more
- 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.
Read the detailed description
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:
- Acute PV isolation success rate.
- Acute success rate of bidirectional block for each linear ablation site.
- Durable success rate of bidirectional block for each linear ablation site at 3-month remapping.
- One-year freedom from atrial tachyarrhythmia recurrence.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Ablation with the PFLotus catheter and Depolar system
- 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
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation with the PFLotus catheter and Depolar systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ablation with the PFLotus catheter and Depolar system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Complete electrical isolation of all pulmonary veins;
- 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.
Measured: Immediate after the ablation procedure
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year post the index ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start22 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanxiong Liu, The Third People's Hospital of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321002
- Sponsor's protocol ID
- PFLotus with DePolar
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Novel Shape-Adaptive Catheter With for Both Single-Shot and Large-Focal Pulsed Field Ablation the DePolar Mapping System in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07321002
- Acronym / sponsor ID
- PFLotus with DePolar
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The Third People's Hospital of ChengduUniversity, hospital or other
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Acute PV isolation success rate.
- Acute success rate of bidirectional block for each linear ablation site.
- Durable success rate of bidirectional block for each linear ablation site at 3-month remapping.
- One-year freedom from atrial tachyarrhythmia recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation Group | Experimental | Device: Ablation with the PFLotus catheter and Depolar systemPVI 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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.
- 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 informed consent.
Key exclusion criteria (30 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation with the PFLotus catheter and Depolar systemPVI 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. | Device | Ablation Group |
Primary outcome
Incidence of Primary Adverse Events (PAEs) Within 3 Months Post-Ablation [Primary Safety Endpoint]
Time frame: Within 3 months post the index ablation
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.
Rate of Acute Procedural Success: Complete Pulmonary Vein Isolation and Bidirectional Block at Targeted Linear Ablation Sites [Primary Efficacy Endpoint]
Time frame: Immediate after the ablation procedure
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.
4 secondary outcomes
Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint]
Time frame: Immediate after the index ablation procedure
Acute Bidirectional Block Success Rate for Each Targeted Linear Ablation Site [Secondary Efficacy Endpoint]
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]
Time frame: 3 months post the index ablation procedure
1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint]
Time frame: 1 year post the index ablation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation with the PFLotus catheter and Depolar system in people with Persistent Atrial Fibrillation, run by The Third People's Hospital of Chengdu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiqiang Xiong, Doctor of Medicine (8619980510703, xionglliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Primary Adverse Events (PAEs) Within 3 Months Post-Ablation [Primary Safety Endpoint] (time frame: Within 3 months post the index ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.