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

9. september 2026 opdateret af: 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)

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

208

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100029
        • Rekruttering
        • Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
Enhed: 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.
Medicin: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Aktiv komparator: no Device group (Control Group)
Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only
Medicin: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Tidsramme: 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）
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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）
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Device-Related Adverse Events
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Anzhen Hospital

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Guangyuan Song, M.D., Beijing Anzhen Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. november 2024

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. september 2026

Først opslået (Faktiske)

15. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • BeijingAnzhen20260716

Plan for individuelle deltagerdata (IPD)

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