Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation (SAVE-AF)
23 de julho de 2026 atualizado por: Qiang Hu
Efficacy and Safety of Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation by Pulsed Field Ablation for Treatment of Atrial Fibrillation
Atrial fibrillation (AF) is one of the most concerning diseases in the field of cardiac arrhythmias.
It is a type of rapid supraventricular arrhythmia characterized by rapid and disorganized contraction of the atria, which leads to ventricular rate disturbance, impaired cardiac function, and an increased risk of atrial mural thrombus formation.
AF severely reduces patients' quality of life and can cause complications such as heart failure, stroke, and sudden death.
Currently, the vast majority of AF episodes are triggered by pulmonary vein (PV) ectopic foci.
Therefore, catheter ablation is the preferred treatment strategy, with pulmonary vein isolation (PVI) being the cornerstone procedure.
However, a small proportion of patients may have non-PV triggers, particularly originating from the superior vena cava (SVC).
Conventional radiofrequency ablation (RFA) for SVC isolation carries unpredictable risks, including damage to the sinus node and the phrenic nerve.
Therefore, this study aims to investigate the impact of empirical SVC electrical isolation in addition to PVI on the success rate of AF ablation, using pulsed field ablation (PFA)-a non-thermal ablation modality with tissue selectivity and a favorable safety profile.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
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: Qiang Hu, Doctor
- Número de telefone: +8602886590223
- E-mail: huqiang071@foxmail.com
Locais de estudo
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Sichuan
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Chengdu, Sichuan, China, 610000
- Recrutamento
- Qiang Hu
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Contato:
- Qiang Hu, Doctor
- Número de telefone: +8602886590223
- E-mail: huqiang071@foxmail.com
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-
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;
- Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months;
- Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China;
- Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy;
- Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.
Exclusion Criteria:
- Prior surgical or catheter ablation for any type of cardiac arrhythmia;
- AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
- Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
- Sinus node dysfunction or other indications for permanent pacemaker implantation;
- Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
- Left atrial anteroposterior diameter ≥ 50 mm;
- Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure;
- Serum creatinine > 2 times the upper limit of normal, or currently on dialysis;
- History of prior cardiothoracic surgery;
- History of permanent pacemaker implantation;
- History of malignancy;
- Long-term use of a central venous catheter;
- Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
- History of allergy to contrast;
- Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period;
- Subjects or their legally authorized representatives who are unwilling to provide written informed consent;
- Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits;
- Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: superior vena cava isolation plus pulmonary vein isolation
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Eligible patients with atrial fibrillation who are randomized to the experimental group will undergo superior vena cava (SVC) electrical isolation in addition to pulmonary vein isolation (PVI) during the pulsed field ablation procedure
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Comparador Ativo: pulmonary vein isolation
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Eligible patients with atrial fibrillation who are randomized to the control group will undergo pulmonary vein isolation (PVI) during the pulsed field ablation procedure
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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the success rate of atrial fibrillation ablation
Prazo: at 3 month
|
it is assessed by 7-day Holter monitoring
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at 3 month
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
the success rate of atrial fibrillation ablation
Prazo: at 6 month and 12 month
|
it is assessed by 7-day Holter monitoring
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at 6 month and 12 month
|
|
left ventricular end-systolic diameter
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular end-diastolic diameter
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular posterior wall thickness
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
interventricular septal thickness
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular ejection fraction
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/A
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/e'
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial volume index
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial anteroposterior diameter
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial strain
Prazo: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
New York Heart Association class
Prazo: at 3 month, 6 month and 12 month
|
The NYHA is measured by Classification of NYHA heart function
|
at 3 month, 6 month and 12 month
|
|
Major adverse events
Prazo: at 3 month, 6 month and 12 month
|
Major adverse events is a composite endpoint of death, stroke, and myocardial infarction.
|
at 3 month, 6 month and 12 month
|
|
6-min walk distance
Prazo: at 3 month, 6 month and 12 month
|
During the test, patients were asked to walk for 6 minutes on a long corridor with a length of 37.5 meters between the 2 marks
|
at 3 month, 6 month and 12 month
|
|
red blood cell count
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
hemoglobin
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
white blood cell count
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
platelet count
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
alanine aminotransferase
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
aspartate aminotransferase
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
creatinine
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
urea
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
estimated glomerular filtration rate
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
activated partial thromboplastin time
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
prothrombin time
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
international normalized ratio
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
B-type natriuretic peptide
Prazo: at 3 month, 6 month and 12 month
|
It is obtained from a blood sample.
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at 3 month, 6 month and 12 month
|
|
Atrial Fibrillation Effect on Quality of Life Questionnaire
Prazo: at 3 month, 6 month and 12 month
|
AFEQT questionnaire was used to assess the quality of life of patients with atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
|
readmission
Prazo: at 3 month, 6 month and 12 month
|
Rehospitalization was indicated for atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
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 (Real)
20 de julho de 2026
Conclusão Primária (Estimado)
31 de março de 2029
Conclusão do estudo (Estimado)
31 de março de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2026
Primeira postagem (Real)
24 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- N2026-07
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
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