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Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction (PAST-HFrEF)

9. září 2026 aktualizováno: 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)

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Odhadovaný)

208

Fáze

  • Fáze 2
  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína, 100029
        • Nábor
        • Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
Přístroj: D-shant Atrial Shunt
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.
Lék: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Aktivní komparátor: no Device group (Control Group)
Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only
Lék: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Časové okno: 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）
Časové okno: From enrollment to the end of treatment at 12 months
Change in New York Heart Association (NYHA) Functional Classification
From enrollment to the end of treatment at 12 months
Change in NT-proBNP levels
Časové okno: 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
Časové okno: 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)
Časové okno: 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.
From enrollment to the end of treatment at 12 months
Changes in 12-lead Electrocardiogram (ECG)
Časové okno: From enrollment to the end of treatment at 12 months
Presence of arrhythmias
From enrollment to the end of treatment at 12 months
Shunt Orifice Patency/Occlusion Status (Treatment Group)
Časové okno: 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
Časové okno: 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
Časové okno: 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）
Časové okno: From enrollment to the end of treatment at 12 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
From enrollment to the end of treatment at 12 months
Right atrial diameter
Časové okno: From enrollment to the end of treatment at 12 months
Echocardiographic right atrial diameter
From enrollment to the end of treatment at 12 months
Left ventricular diameter
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Shunt flow direction
Časové okno: 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)
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Device-Related Adverse Events
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Beijing Anzhen Hospital

Spolupracovníci

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Vyšetřovatelé

  • Vrchní vyšetřovatel: Guangyuan Song, M.D., Beijing Anzhen Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

25. listopadu 2024

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

16. července 2026

První předloženo, které splnilo kritéria kontroly kvality

9. září 2026

První zveřejněno (Aktuální)

15. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • BeijingAnzhen20260716

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