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

NCT07627685 | Not Yet Recruiting

• 1 other identifier: POTENTIAL-AF
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Pulsed Field Ablation; Catheter Ablation; Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality

  Death from any cause from the time of enrolment to end of follow-up

  From enrolment to 10 years

Secondary Outcomes (9)

• Ischaemic Stroke

  5 years from enrolment

• Haemorrhagic Stroke

  5 years from enrolment

• Transient Ischaemic Attack (TIA)

  5 years from enrolment

• Cardiovascular Death

  5 years from enrolment

• Cardiovascular Hospitalisation

  5 years from enrolment

Study Arms (1)

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

Interventions

Bi-polar Pulse-field Ablation (PFA) - LEAD-PFA System with PulsedFA catheter DEVICE

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.

PFA Ablation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years
• 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
• Failure of AAD therapy: inadequate efficacy and/or intolerance to ≥ 1 Class I or Class III antiarrhythmic drug
• Planned PFA catheter ablation for AF
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Song Zuo, MD

CONTACT

+8618801427775; song_zuo@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2036
• Study Completion (Estimated): September 30, 2036
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)