Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction (PAST-HFrEF)
9 de setembro de 2026 atualizado por: Guangyuan Song, Beijing Anzhen Hospital
A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
This is a prospective, randomized, open-label, parallel-controlled, superiority, multicenter clinical study. A total of 208 subjects will be randomized 1:1 after meeting all inclusion/exclusion criteria.
Treatment Group: atrial shunt implantation post-right heart catheterization. Control Group: Right heart catheterization only. Both groups will receive standardized Guideline-Directed Medical Therapy (GDMT) post-procedure. Assessments and follow-ups will be conducted at pre-procedure baseline, day of procedure, 1 week, 1 month, 3 months, 6 months, and 12 months post-procedure.
A Clinical Event Committee (CEC), composed of third-party cardiovascular experts, will independently review and adjudicate primary endpoints in a blinded manner (surgical information concealed).
Tipo de estudo
Intervencional
Inscrição (Estimado)
208
Estágio
- Fase 2
- Fase 3
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: Sanshuai Chang, M.D.
- Número de telefone: +8618501369869
- E-mail: 18501369869@163.com
Estude backup de contato
- Nome: Guangyuan Song, M.D.
- Número de telefone: +8613801120805
- E-mail: songgy_anzhen@vip.163.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100029
- Recrutamento
- Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
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Contato:
- Sanshuai Chang, M.D.
- Número de telefone: +8618501369869
- E-mail: 18501369869@163.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:
- 1. Age ≥ 18 years 2. Diagnosed with HFrEF and receiving Guideline-Directed Medical Therapy (GDMT) for at least 1 month 3. Echocardiographic LVEF between 20% and 40% (20 ≤ LVEF ≤ 40%) 4. Presence of HF-related symptoms and signs, NYHA Class III 5. At least one HF-related hospitalization in the past year or NT-proBNP ≥ 600 pg/mL (sinus rhythm) / ≥ 1000 pg/mL (atrial fibrillation) 6. Invasive hemodynamics: mLAP or mPCWP ≥ 15 mmHg, or left-to-right mean pressure gradient ≥ 5 mmHg 7. Fully understand the study design and follow-up schedule, agrees to participate, and voluntarily signs the Informed Consent Form
Exclusion Criteria:
- 1. End-stage heart failure on the heart transplant waiting list (including meeting LVAD indications) 2. Three consecutive non-invasive systolic blood pressure readings < 90 mmHg 3. Primary structural valvular disease currently indicating surgery or interventional therapy, or severe coronary artery disease requiring revascularization 4. ECG QRS duration ≥ 130 ms with high risk of sudden cardiac death without therapeutic intervention (including meeting CRT/CRT-D indications) 5. Significant right ventricular (RV) dysfunction or severe pulmonary hypertension. Defined by clinical evidence of hepatic congestion, moderate-to-severe edema, or abdominal distension accompanied by poor appetite; significant right atrial or RV enlargement/dysfunction; moderate-to-severe tricuspid regurgitation; mean right atrial pressure > 10 mmHg; systolic pulmonary artery pressure > 60 mmHg; or pulmonary vascular resistance > 3 Wood Units 6. Myocardial infarction or cardiac intervention within the past 1 month 7. Stroke within the past 1 month (excluding lacunar infarction) 8. Decompensated liver cirrhosis (Child-Pugh Class B or worse), or severe chronic pulmonary disease requiring oxygen therapy 9. Anatomical abnormalities precluding procedure completion or making the patient unsuitable for procedure 10. Atrial thrombosis 11. Contraindication to antithrombotic therapy 12. Life expectancy < 1 year 13. Uncontrolled active infection 14. Pregnant, lactating, or women of childbearing potential planning pregnancy in the near future 15. Currently participating in another drug or medical device clinical trial 16. Investigator deems the patient unsuitable for this 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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
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The D-Shant atrial shunt device is a novel device therapy for heart failure, classified as a non-active implantable cardiovascular device.
It is manufactured using a braided Nitinol technique, thermally set via assembly molds to form a waist with a fixed-orifice support and a hollow double-disc structure.
Braided wires reinforce waist support and maintain a circular orifice shape.
Once implanted, it forms a stable interatrial shunt.
The device is delivered via the femoral vein to the interatrial septum, where the shunt orifice facilitates blood flow diversion and pressure decompression.
Various models with different waist and disc diameters are available to accommodate varying degrees and etiologies of heart failure.
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
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Comparador Ativo: no Device group (Control Group)
Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only
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Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months
Prazo: From enrollment to the end of treatment at 12 months
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A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months.
Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or <24 hours if subject dies in the emergency room).
- Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay <24 hours.
- Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy
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From enrollment to the end of treatment at 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Prazo: From enrollment to the end of treatment at 12 months
|
Change in exercise capacity post-procedure: 6-Minute Walk Test
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From enrollment to the end of treatment at 12 months
|
|
New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome）
Prazo: From enrollment to the end of treatment at 12 months
|
Change in New York Heart Association (NYHA) Functional Classification
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From enrollment to the end of treatment at 12 months
|
|
Change in NT-proBNP levels
Prazo: From enrollment to the end of treatment at 12 months
|
Change in NT-proBNP levels
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From enrollment to the end of treatment at 12 months
|
|
Left atrial diameter
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic Left atrial diameter
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From enrollment to the end of treatment at 12 months
|
|
Device Success Rates (Treatment Group)
Prazo: From enrollment to the end of treatment at 12 months
|
Device Success is defined as successful implantation of the shunt with normal morphology and position, visible left-to-right shunt on echocardiography, and an immediate decrease in mean Left Atrial Pressure (mLAP) or mean Pulmonary Capillary Wedge Pressure (mPCWP) compared to pre-implantation.
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From enrollment to the end of treatment at 12 months
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Changes in 12-lead Electrocardiogram (ECG)
Prazo: From enrollment to the end of treatment at 12 months
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Presence of arrhythmias
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From enrollment to the end of treatment at 12 months
|
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Shunt Orifice Patency/Occlusion Status (Treatment Group)
Prazo: From enrollment to the end of treatment at 12 months
|
Shunt Orifice Patency/Occlusion Status (Treatment Group)
|
From enrollment to the end of treatment at 12 months
|
|
All-cause mortality rate
Prazo: From enrollment to the end of treatment at 12 months
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All-cause mortality rate
|
From enrollment to the end of treatment at 12 months
|
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Number of HF-related rehospitalizations post-procedure
Prazo: From enrollment to the end of treatment at 12 months
|
Number of HF-related rehospitalizations post-procedure
|
From enrollment to the end of treatment at 12 months
|
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Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome）
Prazo: From enrollment to the end of treatment at 12 months
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
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From enrollment to the end of treatment at 12 months
|
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Right atrial diameter
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic right atrial diameter
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From enrollment to the end of treatment at 12 months
|
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Left ventricular diameter
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic left ventricular diameter
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From enrollment to the end of treatment at 12 months
|
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Right ventricular diameter
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic reft atrial diameter
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From enrollment to the end of treatment at 12 months
|
|
Left Ventricular Ejection Fraction
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic Left Ventricular Ejection Fraction
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From enrollment to the end of treatment at 12 months
|
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Tricuspid Annular Plane Systolic Excursion
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic Tricuspid Annular Plane Systolic Excursion
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From enrollment to the end of treatment at 12 months
|
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Right Ventricular Fractional Area
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic Right Ventricular Fractional Area
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From enrollment to the end of treatment at 12 months
|
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Aortic regurgitation
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic aortic regurgitation
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From enrollment to the end of treatment at 12 months
|
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Mitral regurgitation
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic mitral regurgitation
|
From enrollment to the end of treatment at 12 months
|
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Tricuspid regurgitation
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic tricuspid regurgitation
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From enrollment to the end of treatment at 12 months
|
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Shunt orifice diameter
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic Shunt orifice diameter
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From enrollment to the end of treatment at 12 months
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Shunt flow velocity
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic shunt flow velocity
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From enrollment to the end of treatment at 12 months
|
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Trans-shunt pressure gradient
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic trans-shunt pressure gradient
|
From enrollment to the end of treatment at 12 months
|
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Shunt flow direction
Prazo: From enrollment to the end of treatment at 12 months
|
Echocardiographic shunt flow direction
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From enrollment to the end of treatment at 12 months
|
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Procedural Success Rates (Treatment Group)
Prazo: From enrollment to the end of treatment at 12 months
|
Procedural Success is defined as achieving Device Success with the patient surviving to hospital discharge.
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From enrollment to the end of treatment at 12 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Device-Related Adverse Events
Prazo: From enrollment to the end of treatment at 12 months
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Cardiac tamponade Air embolism Systemic embolization syndrome Thrombus formation on the device surface Device malfunction requiring emergency surgical removal
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From enrollment to the end of treatment at 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Guangyuan Song, M.D., Beijing Anzhen Hospital
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)
25 de novembro de 2024
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de setembro de 2026
Primeira postagem (Real)
15 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- BeijingAnzhen20260716
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