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Not yet recruiting NCT07627685

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

— Observational Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bi-polar Pulse-field Ablation (PFA) - LEAD-PFA System with PulsedFA catheter.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 pulmona

Primary outcome measures

  • All-Cause Mortality [Time frame: From enrolment to 10 years]
Secondary outcome measures (9)
  • Ischaemic Stroke [Time frame: 5 years from enrolment]
  • Haemorrhagic Stroke [Time frame: 5 years from enrolment]
  • Transient Ischaemic Attack (TIA) [Time frame: 5 years from enrolment]
  • Cardiovascular Death [Time frame: 5 years from enrolment]
  • Cardiovascular Hospitalisation [Time frame: 5 years from enrolment]
  • Systemic Embolism [Time frame: 5 years from enrolment]
  • Thromboembolic Death [Time frame: 5 years from enrolment]
  • Major Bleeding (ISTH Definition) [Time frame: 5 years from enrolment]
  • Clinically Relevant Non-Major Bleeding (CRNMB) [Time frame: 5 years from enrolment]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT07627685 · POTENTIAL-AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗