Prospective Study on the Effectiveness and Safety of Bi-polar Pulse-field Tip-catheter Ablation for Atrial Fibrillation in China（POTENTIAL-AF） (POTENTIAL-AF)

POTENTIAL-AF is a prospective, multicentre, observational registry study evaluating the real-world effectiveness and safety of bi-polar pulse-field tip-catheter ablation (PFA) for atrial fibrillation (AF) in China. The study will enrol 30,000 adult patients with symptomatic paroxysmal or persistent AF who have failed at least one antiarrhythmic drug (Class I or III) and are planned to undergo PFA using the Jinjiang LEAD-PFA system with PulsedFA catheter at participating centres across China.

All procedural decisions, including energy settings, ablation targets, and peri-procedural management, are made by the treating physician per routine clinical practice. The study prospectively collects baseline clinical characteristics, intraoperative ablation parameters, and follow-up outcomes at 3 months, 6 months, 12 months, and every 6 months thereafter, for up to 10 years.

The primary endpoint is all-cause mortality at 10 years. Secondary endpoints (observed over 5 years) include ischaemic stroke, haemorrhagic stroke, transient ischaemic attack (TIA), cardiovascular death, cardiovascular hospitalisation, systemic embolism, thromboembolic death, major bleeding, and clinically relevant non-major bleeding (CRNMB).

By capturing large-scale, standardised, long-term data across diverse Chinese centres, POTENTIAL-AF aims to describe real-world procedural practice patterns, identify predictors of clinical outcomes, and provide evidence to support the safe and effective application of the Jinjiang bi-polar tip PFA catheter in Chinese AF patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Bi-polar Pulse-field Ablation (PFA) - LEAD-PFA System with PulsedFA catheter

• Study Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

• Study Contact: Name: Song Zuo, MD; Phone Number: +8618801427775; Email: song_zuo@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100020
      • Beijing Anzhen Hospital
      • Contact: Song Zuo, MD; Phone Number: +8618801427775; Email: song_zuo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with symptomatic paroxysmal or persistent atrial fibrillation who have failed at least one Class I or III antiarrhythmic drug and are scheduled to undergo bi-polar pulse-field catheter ablation using the Jinjiang LEAD-PFA system at participating centres in China. Patients are consecutively enrolled across multiple centres nationwide. Patients with AF due to reversible causes or with life expectancy less than one year are excluded.

Description

Inclusion Criteria:

1. Age ≥ 18 years

2. Symptomatic paroxysmal AF or persistent AF:

   • Paroxysmal AF: self-terminating within ≤ 7 days; ≥ 2 symptomatic episodes in the 6 months prior to enrolment; ≥ 1 ECG or Holter-documented AF episode in the 12 months prior to enrolment
   • Persistent AF: duration > 7 days and < 1 year; ≥ 1 symptomatic episode in the 6 months prior; documented by Holter or 2 ECGs ≥ 7 days apart within 12 months prior
3. Failure of AAD therapy: inadequate efficacy and/or intolerance to ≥ 1 Class I or Class III antiarrhythmic drug
4. Planned PFA catheter ablation for AF
5. Voluntary participation with written informed consent Willing and able to comply with study procedures and follow-up (including in-hospital assessment, 30-day and 90-day follow-up)

Exclusion Criteria:

1. AF attributable to a reversible cause (e.g., hyperthyroidism, peri-operative or cardiac/thoracic surgery-related AF)
2. Concomitant condition with expected survival < 1 year (e.g., advanced malignancy)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

PFA Ablation Cohort; All enrolled patients undergoing bi-polar pulse-field ablation for atrial fibrillation using the Jinjiang LEAD-PFA system with PulsedFA catheter at participating centres. Peri-procedural management and post-procedural medical therapy are at the treating physician's clinical discretion; no additional protocol-mandated treatment is assigned.

Device: Bi-polar Pulse-field Ablation (PFA) - LEAD-PFA System with PulsedFA catheter; Participants undergo catheter ablation for atrial fibrillation using the Jinjiang bi-polar pulse-field ablation (PFA) system, comprising the LEAD-PFA generator and PulsedFA circular catheter (Jinjiang Electronic Medical Technology Co., Ltd., Sichuan, China). Catheter size (15 mm, 18 mm, or 25 mm) is selected by the operator based on individual anatomy. All patients undergo pulmonary vein isolation (PVI) as the mandatory ablation target. A minimum of 12 PFA applications are delivered per pulmonary vein (≥ 48 applications in total). Energy is delivered in bipolar mode at 2.0 kV, with each application comprising 5 pulse sequences over 2.5 seconds, non-synchronised to the QRS complex. Electrophysiological verification of entrance block (and exit block where applicable) is performed after PVI; additional applications are permitted if acute conduction recovery is observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality	Death from any cause from the time of enrolment to end of follow-up	From enrolment to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischaemic Stroke	Acute neurological deficit caused by focal cerebral, spinal, or retinal infarction; confirmed by CT/MRI neuroimaging or criteria for permanent tissue injury	5 years from enrolment
Haemorrhagic Stroke	Intracerebral or subarachnoid haemorrhage due to cerebrovascular rupture (including intracerebral haemorrhage and subarachnoid haemorrhage)	5 years from enrolment
Transient Ischaemic Attack (TIA)	Sudden focal neurological deficit lasting < 24 hours without evidence of acute infarction on neuroimaging	5 years from enrolment
Cardiovascular Death	Death caused by acute MI, sudden cardiac death, heart failure, stroke, fatal bleeding, or cardiovascular intervention-related complications	5 years from enrolment
Cardiovascular Hospitalisation	Unplanned hospitalisation for ACS, worsening heart failure, arrhythmia, stroke, cardiovascular procedure, thromboembolic or haemorrhagic complications	5 years from enrolment
Systemic Embolism	Acute arterial embolism outside the central nervous system confirmed by imaging or surgery with evidence of embolic source; pulmonary embolism excluded	5 years from enrolment
Thromboembolic Death	Death occurring in the context of confirmed or suspected thromboembolic event (ischaemic stroke or systemic embolism) with no other definitive non-cardiovascular explanation	5 years from enrolment
Major Bleeding (ISTH Definition)	Fatal bleeding; OR symptomatic bleeding in a critical area or organ; OR bleeding causing a fall in haemoglobin of ≥ 2 g/dL or leading to transfusion of ≥ 2 units of whole blood or red blood cells - per ISTH 2005 criteria	5 years from enrolment
Clinically Relevant Non-Major Bleeding (CRNMB)	Bleeding not meeting major bleeding criteria but associated with medical intervention, unplanned medical visit, temporary interruption of treatment, or pain/impairment of daily activities	5 years from enrolment

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2036
• Study Completion (Estimated): September 30, 2036

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Catheter Ablation; Pulmonary Vein Isolation; Pulsed Field Ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: POTENTIAL-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No