Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction (PAST-HFrEF)
9 сентября 2026 г. обновлено: 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)
Обзор исследования
Статус
Рекрутинг
Подробное описание
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).
Тип исследования
Интервенционный
Регистрация (Оцененный)
208
Фаза
- Фаза 2
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Sanshuai Chang, M.D.
- Номер телефона: +8618501369869
- Электронная почта: 18501369869@163.com
Учебное резервное копирование контактов
- Имя: Guangyuan Song, M.D.
- Номер телефона: +8613801120805
- Электронная почта: songgy_anzhen@vip.163.com
Места учебы
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Китай, 100029
- Рекрутинг
- Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
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Контакт:
- Sanshuai Chang, M.D.
- Номер телефона: +8618501369869
- Электронная почта: 18501369869@163.com
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
|
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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Активный компаратор: 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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
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
Временное ограничение: From enrollment to the end of treatment at 12 months
|
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
|
From enrollment to the end of treatment at 12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Change in exercise capacity post-procedure: 6-Minute Walk Test
|
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）
Временное ограничение: 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
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Change in NT-proBNP levels
|
From enrollment to the end of treatment at 12 months
|
|
Left atrial diameter
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic Left atrial diameter
|
From enrollment to the end of treatment at 12 months
|
|
Device Success Rates (Treatment Group)
Временное ограничение: 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)
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Presence of arrhythmias
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From enrollment to the end of treatment at 12 months
|
|
Shunt Orifice Patency/Occlusion Status (Treatment Group)
Временное ограничение: 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
Временное ограничение: From enrollment to the end of treatment at 12 months
|
All-cause mortality rate
|
From enrollment to the end of treatment at 12 months
|
|
Number of HF-related rehospitalizations post-procedure
Временное ограничение: 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
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome）
Временное ограничение: 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
|
|
Right atrial diameter
Временное ограничение: 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
|
|
Left ventricular diameter
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic left ventricular diameter
|
From enrollment to the end of treatment at 12 months
|
|
Right ventricular diameter
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic reft atrial diameter
|
From enrollment to the end of treatment at 12 months
|
|
Left Ventricular Ejection Fraction
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic Left Ventricular Ejection Fraction
|
From enrollment to the end of treatment at 12 months
|
|
Tricuspid Annular Plane Systolic Excursion
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic Tricuspid Annular Plane Systolic Excursion
|
From enrollment to the end of treatment at 12 months
|
|
Right Ventricular Fractional Area
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic Right Ventricular Fractional Area
|
From enrollment to the end of treatment at 12 months
|
|
Aortic regurgitation
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic aortic regurgitation
|
From enrollment to the end of treatment at 12 months
|
|
Mitral regurgitation
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic mitral regurgitation
|
From enrollment to the end of treatment at 12 months
|
|
Tricuspid regurgitation
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic tricuspid regurgitation
|
From enrollment to the end of treatment at 12 months
|
|
Shunt orifice diameter
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic Shunt orifice diameter
|
From enrollment to the end of treatment at 12 months
|
|
Shunt flow velocity
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic shunt flow velocity
|
From enrollment to the end of treatment at 12 months
|
|
Trans-shunt pressure gradient
Временное ограничение: 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
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Echocardiographic shunt flow direction
|
From enrollment to the end of treatment at 12 months
|
|
Procedural Success Rates (Treatment Group)
Временное ограничение: 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.
|
From enrollment to the end of treatment at 12 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Device-Related Adverse Events
Временное ограничение: From enrollment to the end of treatment at 12 months
|
Cardiac tamponade Air embolism Systemic embolization syndrome Thrombus formation on the device surface Device malfunction requiring emergency surgical removal
|
From enrollment to the end of treatment at 12 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Guangyuan Song, M.D., Beijing Anzhen Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
25 ноября 2024 г.
Первичное завершение (Оцененный)
31 декабря 2027 г.
Завершение исследования (Оцененный)
31 декабря 2027 г.
Даты регистрации исследования
Первый отправленный
16 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
9 сентября 2026 г.
Первый опубликованный (Действительный)
15 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- BeijingAnzhen20260716
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .