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

31 mei 2026 bijgewerkt door: Beijing Anzhen Hospital

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

30000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Beijing Anzhen Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
All-Cause Mortality
Tijdsspanne: From enrolment to 10 years
Death from any cause from the time of enrolment to end of follow-up
From enrolment to 10 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Ischaemic Stroke
Tijdsspanne: 5 years from enrolment
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
Tijdsspanne: 5 years from enrolment
Intracerebral or subarachnoid haemorrhage due to cerebrovascular rupture (including intracerebral haemorrhage and subarachnoid haemorrhage)
5 years from enrolment
Transient Ischaemic Attack (TIA)
Tijdsspanne: 5 years from enrolment
Sudden focal neurological deficit lasting < 24 hours without evidence of acute infarction on neuroimaging
5 years from enrolment
Cardiovascular Death
Tijdsspanne: 5 years from enrolment
Death caused by acute MI, sudden cardiac death, heart failure, stroke, fatal bleeding, or cardiovascular intervention-related complications
5 years from enrolment
Cardiovascular Hospitalisation
Tijdsspanne: 5 years from enrolment
Unplanned hospitalisation for ACS, worsening heart failure, arrhythmia, stroke, cardiovascular procedure, thromboembolic or haemorrhagic complications
5 years from enrolment
Systemic Embolism
Tijdsspanne: 5 years from enrolment
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
Tijdsspanne: 5 years from enrolment
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)
Tijdsspanne: 5 years from enrolment
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)
Tijdsspanne: 5 years from enrolment
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beijing Anzhen Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2036

Studie voltooiing (Geschat)

30 september 2036

Studieregistratiedata

Eerst ingediend

31 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

31 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • POTENTIAL-AF

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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