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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 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

30000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100020
        • Beijing Anzhen Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
All-Cause Mortality
Tidsram: From enrolment to 10 years
Death from any cause from the time of enrolment to end of follow-up
From enrolment to 10 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ischaemic Stroke
Tidsram: 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
Tidsram: 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)
Tidsram: 5 years from enrolment
Sudden focal neurological deficit lasting < 24 hours without evidence of acute infarction on neuroimaging
5 years from enrolment
Cardiovascular Death
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beijing Anzhen Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2036

Avslutad studie (Beräknad)

30 september 2036

Studieregistreringsdatum

Först inskickad

31 maj 2026

Först inskickad som uppfyllde QC-kriterierna

31 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • POTENTIAL-AF

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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