An observational study in Atrial Fibrillation, sponsored by Beijing Anzhen Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Beijing Anzhen Hospital · Observational
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.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 300 across 1,362 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Beijing Anzhen Hospital is the lead sponsor of 188 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Symptomatic paroxysmal AF or persistent AF:
Exclusion Criteria:
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.
All-Cause Mortality
Death from any cause from the time of enrolment to end of follow-up
Time frame: From enrolment to 10 years
Ischaemic Stroke
Acute neurological deficit caused by focal cerebral, spinal, or retinal infarction; confirmed by CT/MRI neuroimaging or criteria for permanent tissue injury
Time frame: 5 years from enrolment
Haemorrhagic Stroke
Intracerebral or subarachnoid haemorrhage due to cerebrovascular rupture (including intracerebral haemorrhage and subarachnoid haemorrhage)
Time frame: 5 years from enrolment
Transient Ischaemic Attack (TIA)
Sudden focal neurological deficit lasting \< 24 hours without evidence of acute infarction on neuroimaging
Time frame: 5 years from enrolment
Cardiovascular Death
Death caused by acute MI, sudden cardiac death, heart failure, stroke, fatal bleeding, or cardiovascular intervention-related complications
Time frame: 5 years from enrolment
Cardiovascular Hospitalisation
Unplanned hospitalisation for ACS, worsening heart failure, arrhythmia, stroke, cardiovascular procedure, thromboembolic or haemorrhagic complications
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years from enrolment
Plan to share: No
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Beijing Anzhen Hospital