Prospective Study on the Effectiveness and Safety of Bi-polar Pulse-field Tip-catheter Ablation for Atrial Fibrillation in China（POTENTIAL-AF） (POTENTIAL-AF)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Song Zuo, MD
- Numéro de téléphone: +8618801427775
- E-mail: song_zuo@126.com
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100020
- Beijing Anzhen Hospital
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Contact:
- Song Zuo, MD
- Numéro de téléphone: +8618801427775
- E-mail: song_zuo@126.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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All-Cause Mortality
Délai: From enrolment to 10 years
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Death from any cause from the time of enrolment to end of follow-up
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From enrolment to 10 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Ischaemic Stroke
Délai: 5 years from enrolment
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Acute neurological deficit caused by focal cerebral, spinal, or retinal infarction; confirmed by CT/MRI neuroimaging or criteria for permanent tissue injury
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5 years from enrolment
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Haemorrhagic Stroke
Délai: 5 years from enrolment
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Intracerebral or subarachnoid haemorrhage due to cerebrovascular rupture (including intracerebral haemorrhage and subarachnoid haemorrhage)
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5 years from enrolment
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Transient Ischaemic Attack (TIA)
Délai: 5 years from enrolment
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Sudden focal neurological deficit lasting < 24 hours without evidence of acute infarction on neuroimaging
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5 years from enrolment
|
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Cardiovascular Death
Délai: 5 years from enrolment
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Death caused by acute MI, sudden cardiac death, heart failure, stroke, fatal bleeding, or cardiovascular intervention-related complications
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5 years from enrolment
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Cardiovascular Hospitalisation
Délai: 5 years from enrolment
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Unplanned hospitalisation for ACS, worsening heart failure, arrhythmia, stroke, cardiovascular procedure, thromboembolic or haemorrhagic complications
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5 years from enrolment
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Systemic Embolism
Délai: 5 years from enrolment
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Acute arterial embolism outside the central nervous system confirmed by imaging or surgery with evidence of embolic source; pulmonary embolism excluded
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5 years from enrolment
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Thromboembolic Death
Délai: 5 years from enrolment
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Death occurring in the context of confirmed or suspected thromboembolic event (ischaemic stroke or systemic embolism) with no other definitive non-cardiovascular explanation
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5 years from enrolment
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Major Bleeding (ISTH Definition)
Délai: 5 years from enrolment
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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
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5 years from enrolment
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Clinically Relevant Non-Major Bleeding (CRNMB)
Délai: 5 years from enrolment
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Bleeding not meeting major bleeding criteria but associated with medical intervention, unplanned medical visit, temporary interruption of treatment, or pain/impairment of daily activities
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5 years from enrolment
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- POTENTIAL-AF
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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