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

9 septembre 2026 mis à jour par: 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)

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Estimé)

208

Phase

  • Phase 2
  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100029
        • Recrutement
        • Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
Dispositif: 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.
Médicament: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Comparateur actif: no Device group (Control Group)
Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only
Médicament: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Délai: 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）
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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）
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Device-Related Adverse Events
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beijing Anzhen Hospital

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Guangyuan Song, M.D., Beijing Anzhen Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 novembre 2024

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

16 juillet 2026

Première soumission répondant aux critères de contrôle qualité

9 septembre 2026

Première publication (Réel)

15 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • BeijingAnzhen20260716

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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