- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07820410
Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction (PAST-HFrEF)
A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
Descripción general del estudio
Estado
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sanshuai Chang, M.D.
- Número de teléfono: +8618501369869
- Correo electrónico: 18501369869@163.com
Copia de seguridad de contactos de estudio
- Nombre: Guangyuan Song, M.D.
- Número de teléfono: +8613801120805
- Correo electrónico: songgy_anzhen@vip.163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Reclutamiento
- Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
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Contacto:
- Sanshuai Chang, M.D.
- Número de teléfono: +8618501369869
- Correo electrónico: 18501369869@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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 activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome)
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Change in exercise capacity post-procedure: 6-Minute Walk Test
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From enrollment to the end of treatment at 12 months
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New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome)
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Change in New York Heart Association (NYHA) Functional Classification
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From enrollment to the end of treatment at 12 months
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Change in NT-proBNP levels
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Change in NT-proBNP levels
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From enrollment to the end of treatment at 12 months
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Left atrial diameter
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Echocardiographic Left atrial diameter
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From enrollment to the end of treatment at 12 months
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Device Success Rates (Treatment Group)
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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)
Periodo de tiempo: 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)
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Shunt Orifice Patency/Occlusion Status (Treatment Group)
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From enrollment to the end of treatment at 12 months
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All-cause mortality rate
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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All-cause mortality rate
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From enrollment to the end of treatment at 12 months
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Number of HF-related rehospitalizations post-procedure
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Number of HF-related rehospitalizations post-procedure
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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)
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Echocardiographic reft atrial diameter
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From enrollment to the end of treatment at 12 months
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Left Ventricular Ejection Fraction
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Echocardiographic aortic regurgitation
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From enrollment to the end of treatment at 12 months
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Mitral regurgitation
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Echocardiographic mitral regurgitation
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From enrollment to the end of treatment at 12 months
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Tricuspid regurgitation
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Echocardiographic tricuspid regurgitation
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From enrollment to the end of treatment at 12 months
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Shunt orifice diameter
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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Echocardiographic trans-shunt pressure gradient
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From enrollment to the end of treatment at 12 months
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Shunt flow direction
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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)
Periodo de tiempo: From enrollment to the end of treatment at 12 months
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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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Device-Related Adverse Events
Periodo de tiempo: 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
Patrocinador
Investigadores
- Investigador principal: Guangyuan Song, M.D., Beijing Anzhen Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- BeijingAnzhen20260716
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .