Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation
3 de setembro de 2026 atualizado por: Shanghai Shineyo Medical Co., Ltd.
A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of Cardiac Pulsed Field Ablation Devices Combined With Single-use Spherical Pulsed Ablation Catheters in Treating Paroxysmal Atrial Fibrillation
The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac three-dimensional mapping system, works to treat symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation. It will also learn about the safety of this set of investigational medical devices. The main questions it aims to answer are:
Does the combination of the cardiac pulsed field ablation device and the single-use spherical pulsed ablation catheter improve the 12-month post-procedure treatment success rate for participants with paroxysmal atrial fibrillation? What adverse events and medical problems do participants experience after receiving the investigational pulsed field ablation treatment? Researchers will compare the investigational pulsed field ablation therapy to the clinically recognized radiofrequency ablation therapy using the marketed Diagnostic/Ablation Deflectable Tip Catheter to verify the non-inferior effectiveness and safety of the test devices for treating paroxysmal atrial fibrillation.
Participants will:
Undergo screening assessments within 14 days before the procedure, including signing informed consent, completing medical history collection, physical vital sign checks, laboratory tests, 12-lead ECG, echocardiogram, baseline quality of life score evaluation, and confirmation of meeting all inclusion criteria without any exclusion criteria Be randomly assigned to either the investigational pulsed field ablation group or the control radiofrequency ablation group on the day of surgery Receive the assigned ablation procedure, with intra-operative recordings of core surgical parameters, pain score assessment, and investigational device performance evaluation Complete post-procedure assessments before discharge (within 7 days after surgery), including post-operative laboratory tests, pain follow-up, and recording of re-ablation, electrical cardioversion, readmission events, adverse events and concomitant medications Return for follow-up visits or complete telephone follow-ups at 1 month (±7 days), 3 months (±15 days), 6 months (±30 days) and 12 months (±30 days) after the procedure, which include physical vital sign checks, remote ECG monitoring (daily for the first 3 months after surgery, weekly from month 4 to month 12, and as needed when symptoms occur), 72-hour Holter and 12-lead ECG tests at the 6-month and 12-month visits, echocardiogram reexamination, repeated quality of life scoring, and continuous recording of arrhythmia recurrence, subsequent treatment events, adverse events and medication status Keep a symptom and ECG monitoring diary for the entire 12-month follow-up period after the procedure, as required by the trial protocol
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
284
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Shuang Pan
- Número de telefone: 86-18621903981
- E-mail: panshuang@shineyomedical.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age ≥18 years and ≤75 years, without gender restriction
- Patients with symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation
- Subjects scheduled for atrial fibrillation catheter ablation
- Subjects who agree to participate in this study and voluntarily sign the informed consent form
Exclusion Criteria:
- Persistent atrial fibrillation, or atrial fibrillation secondary to electrolyte disturbance, thyroid disease, alcohol or other reversible/non-cardiac causes
- Anterior-posterior left atrial diameter (measured by MRI, CT or TTE) ≥55 mm
- Prior history of any atrial surgery or atrial endocardial/epicardial ablation, except cavotricuspid isthmus ablation or right-sided supraventricular tachycardia ablation
- Existing left atrial thrombus, atrial myxoma, atrial septal patch or shunt device
- Prior or planned concomitant left atrial appendage closure procedure at index procedure
- Diagnosis of hypertrophic cardiomyopathy
- History of congenital heart disease with residual anatomical or conduction abnormalities
- Hemodynamically significant valvular heart disease judged by investigator to be ineligible for enrollment
- Prior valve repair or valve replacement surgery
- Implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device
- NYHA functional class Ⅲ-Ⅳ
- Left ventricular ejection fraction (LVEF) ≤40%
- Symptomatic hypotension or uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg in two baseline measurements)
- Symptomatic resting bradycardia or type-second-degree or third-degree atrioventricular block
- Contraindication to systemic anticoagulation, or unwillingness to receive systemic anticoagulation
- Medical conditions that may interfere with study participation, assessment or treatment, significantly increase study-related risk, or alter study outcomes, including but not limited to: moderate-to-severe COPD, moderate-to-severe pulmonary hypertension, or diseases causing severe dyspnea or resting hypoxemia; renal insufficiency (eGFR<30 ml/min/1.73 m²) or history of hemodialysis or renal transplantation; active malignancy or treated malignancy within 24 months prior to enrollment (excluding basal cell or squamous cell skin carcinoma); active systemic infection
- Myocardial infarction, unstable angina, heart failure hospitalization within 3 months prior to enrollment; any cardiac interventional or open-heart surgery within 1 month prior to enrollment (coronary angiography excluded)
- Stroke (excluding silent stroke), transient ischemic attack or any thromboembolic event within 3 months prior to enrollment
- Expected survival less than 1 year
- Female subjects who are pregnant, lactating, or planning pregnancy during study period
- Participation in another interventional device clinical trial within 1 month before enrollment, or within 5 half-lives of last study drug for drug clinical trials
- Any other condition judged by investigator to make the subject unsuitable for this clinical trial
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Investigational Cardiac Pulsed Field Ablation (PFA) Arm
Intervention group receiving cardiac pulsed field ablation for paroxysmal atrial fibrillation
|
It consists of a cardiac pulsed electric field ablation apparatus and a single-use spherical pulsed ablation catheter, which can be paired with an optional cardiac three-dimensional mapping system to complete pulsed electric field ablation in the pulmonary vein antrum region, achieve pulmonary vein electrical isolation, and is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation.
|
|
Comparador Ativo: Control Radiofrequency (RF) Catheter Ablation Arm
Control group receiving conventional radiofrequency catheter ablation for paroxysmal atrial fibrillation
|
Using the commercially available diagnostic/ablation steerable-tip catheter in combination with a conventional clinical radiofrequency ablation device, point-by-point radiofrequency ablation is performed on the pulmonary vein antrum to achieve pulmonary vein electrical isolation.
This is the current standard clinical treatment for paroxysmal atrial fibrillation.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with freedom from atrial fibrillation at 12 months post-index ablation (90-day post-procedure blanking period)
Prazo: 12 months post-index ablation
|
Treatment success at 12 months post-index ablation is defined as no amiodarone use and no repeat ablation during the 3-month post-procedure blanking period, except repeat ablation for CTI-dependent atrial flutter.
Following the end of the blanking period (i.e., 3 months to 12 months after the procedure), subjects shall have no use of Class I/III antiarrhythmic drugs, no repeat ablation, no electrical cardioversion (interventions for CTI-dependent atrial flutter excluded), and no episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds confirmed by electrocardiogram or Holter monitoring (CTI-dependent atrial flutter excluded).
|
12 months post-index ablation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with treatment success at 12 months post-index ablation
Prazo: From the end of 30-day post-procedure blanking period to 12 months after the index ablation
|
From the end of 30-day post-procedure blanking period to 12 months after the index ablation
|
|
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Acute procedural success rate on the day of index ablation
Prazo: On the day of index ablation (intra-procedure completion)
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On the day of index ablation (intra-procedure completion)
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Atrial fibrillation burden assessed by 72-hour Holter monitoring
Prazo: 6-month and 12-month follow-up; daily monitoring 1-3 months post-procedure, weekly monitoring 4-12 months post-procedure, additionally upon symptom occurrence
|
6-month and 12-month follow-up; daily monitoring 1-3 months post-procedure, weekly monitoring 4-12 months post-procedure, additionally upon symptom occurrence
|
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Pain score at 2-hours and 24-hours after index ablation
Prazo: 2 hours after recovery from anesthesia; 24 hours post-index ablation
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2 hours after recovery from anesthesia; 24 hours post-index ablation
|
|
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Recurrence rate of early atrial tachyarrhythmias (atrial fibrillation / atrial flutter / atrial tachycardia)
Prazo: 1-month and 3-month post-index ablation
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1-month and 3-month post-index ablation
|
|
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Proportion of participants receiving electrical cardioversion, repeat ablation, emergency department visit or hospitalization due to documented recurrent atrial arrhythmia
Prazo: Prior to hospital discharge, 1-month, 3-month, 6-month, 12-month post-index ablation
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Prior to hospital discharge, 1-month, 3-month, 6-month, 12-month post-index ablation
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Proportion of participants with re-initiation of antiarrhythmic drugs
Prazo: 1-month, 3-month, 6-month, 12-month post-index ablation
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1-month, 3-month, 6-month, 12-month post-index ablation
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Time from index ablation to first documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia
Prazo: Up to 12-month post-index ablation, assessed at 1-,3-,6-,12-month visits
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Up to 12-month post-index ablation, assessed at 1-,3-,6-,12-month visits
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Symptom-free survival of participants
Prazo: 1-month, 3-month, 6-month, 12-month post-index ablation
|
1-month, 3-month, 6-month, 12-month post-index ablation
|
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Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) total score from baseline
Prazo: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
|
The change from baseline in the total score of the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire.
Measurement tool: AFEQT questionnaire.
Unit: score.
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Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
|
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Performance evaluation of investigational device
Prazo: On the day of index ablation
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On the day of index ablation
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Incidence of major adverse events
Prazo: Within 7 days post-index ablation and up to 12 months post-index ablation
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Within 7 days post-index ablation and up to 12 months post-index ablation
|
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Incidence of device- or procedure-related stroke or transient ischemic attack (TIA)
Prazo: Through study completion, average of 12-month follow-up
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Number of subjects experiencing device- or procedure-related stroke or transient ischemic attack (TIA).
Unit: percentage of subjects.
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Through study completion, average of 12-month follow-up
|
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Incidence of device- related serious adverse events (SAE)
Prazo: Through study completion, average of 12-month follow-up
|
Number of device-related serious adverse events divided by the total number of serious adverse events that occurred during follow-up.
Measurement tool: clinical adverse-event reporting.
Unit: percentage of SAE events.
|
Through study completion, average of 12-month follow-up
|
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Laboratory values of myocardial injury biomarkers
Prazo: Within 48-hours post-index ablation
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Laboratory values of myocardial injury biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first.
Unit: laboratory value.
|
Within 48-hours post-index ablation
|
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Incidence of hemolysis-associated renal injury
Prazo: Within 48-hours post-index ablation
|
Number of subjects with hemolysis-associated renal injury occurring within 48-hours post-index ablation or prior to hospital discharge, whichever comes first.
Unit: percentage of subjects.
|
Within 48-hours post-index ablation
|
|
Incidence of other adverse events (AE)
Prazo: Through study completion, average of 12-month follow-up
|
Number of subjects experiencing other adverse events (AEs) throughout the study period.
Unit: percentage of subjects.
|
Through study completion, average of 12-month follow-up
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Total index ablation procedure duration
Prazo: Periprocedural
|
Total time duration of the index ablation procedure.
Unit: minutes.
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Periprocedural
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Left-atrial device dwell time during index ablation
Prazo: Periprocedural
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Total dwell time of investigational device within left atrium during index ablation.
Unit: minutes.
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Periprocedural
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Pulmonary vein isolation (PVI) procedural time
Prazo: Intra-procedural
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Time spent for pulmonary vein isolation (PVI) manipulation during index ablation.
Unit: minutes.
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Intra-procedural
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Total fluoroscopy time during index ablation
Prazo: Intra-procedural
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Total fluoroscopy exposure time during index ablation.
Unit: minutes.
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Intra-procedural
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Total contrast media volume administered
Prazo: Intra-procedural
|
Total volume of contrast media used during index ablation.
Unit: mL.
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Intra-procedural
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Number of ablation energy deliveries
Prazo: Intra-procedural
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Total count of ablation energy deliveries applied during index ablation.
Unit: number of subjects (count).
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Intra-procedural
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Incidence of other serious adverse events (SAE) throughout the study period
Prazo: Through study completion, average of 12-month follow-up
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Number of subjects with other serious adverse events occurring during the entire study period.
Measurement tool: serious adverse-event reporting.
Unit: percentage of subjects.
|
Through study completion, average of 12-month follow-up
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Laboratory values of inflammatory biomarkers
Prazo: Within 48-hours post-index ablation
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Laboratory values of inflammatory biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first.
Unit: laboratory value.
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Within 48-hours post-index ablation
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Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility score from baseline
Prazo: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
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The change from baseline in the utility index score calculated from the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
Measurement tool: EQ-5D-5L questionnaire.
Unit: index score.
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Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
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Proportion of procedure-related serious adverse events (SAEs) among all SAEs
Prazo: Through study completion, average of 12-month follow-up
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Number of procedure-related serious adverse events divided by the total number of serious adverse events that occurred during follow-up.
Measurement tool: clinical adverse-event reporting.
Unit: percentage of SAE events.
|
Through study completion, average of 12-month follow-up
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de março de 2028
Conclusão do estudo (Estimado)
1 de junho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
20 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de setembro de 2026
Primeira postagem (Real)
10 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- (2026)-(289)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual-participant-level data will not be shared with other researchers.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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