Heart Failure With Reduced Ejection Fraction (HFrEF)
Conditions
Keywords
Heart Failure with Reduced Ejection Fraction, Atrial shunt
Brief summary
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)
Detailed description
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).
Interventions
DEVICED-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.
DRUGGuideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Sponsors
Beijing Anzhen Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome） | From enrollment to the end of treatment at 12 months | Change in exercise capacity post-procedure: 6-Minute Walk Test |
| New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome） | From enrollment to the end of treatment at 12 months | Change in New York Heart Association (NYHA) Functional Classification |
| Change in NT-proBNP levels | From enrollment to the end of treatment at 12 months | Change in NT-proBNP levels |
| Left atrial diameter | From enrollment to the end of treatment at 12 months | Echocardiographic Left atrial diameter |
| Device Success Rates (Treatment Group) | 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. |
| Changes in 12-lead Electrocardiogram (ECG) | From enrollment to the end of treatment at 12 months | Presence of arrhythmias |
| Shunt Orifice Patency/Occlusion Status (Treatment Group) | From enrollment to the end of treatment at 12 months | Shunt Orifice Patency/Occlusion Status (Treatment Group) |
| All-cause mortality rate | From enrollment to the end of treatment at 12 months | All-cause mortality rate |
| Number of HF-related rehospitalizations post-procedure | From enrollment to the end of treatment at 12 months | Number of HF-related rehospitalizations post-procedure |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome） | From enrollment to the end of treatment at 12 months | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score |
| Right atrial diameter | From enrollment to the end of treatment at 12 months | Echocardiographic right atrial diameter |
| Left ventricular diameter | From enrollment to the end of treatment at 12 months | Echocardiographic left ventricular diameter |
| Right ventricular diameter | From enrollment to the end of treatment at 12 months | Echocardiographic reft atrial diameter |
| Left Ventricular Ejection Fraction | From enrollment to the end of treatment at 12 months | Echocardiographic Left Ventricular Ejection Fraction |
| Tricuspid Annular Plane Systolic Excursion | From enrollment to the end of treatment at 12 months | Echocardiographic Tricuspid Annular Plane Systolic Excursion |
| Right Ventricular Fractional Area | From enrollment to the end of treatment at 12 months | Echocardiographic Right Ventricular Fractional Area |
| Aortic regurgitation | From enrollment to the end of treatment at 12 months | Echocardiographic aortic regurgitation |
| Mitral regurgitation | From enrollment to the end of treatment at 12 months | Echocardiographic mitral regurgitation |
| Tricuspid regurgitation | From enrollment to the end of treatment at 12 months | Echocardiographic tricuspid regurgitation |
| Shunt orifice diameter | From enrollment to the end of treatment at 12 months | Echocardiographic Shunt orifice diameter |
| Shunt flow velocity | From enrollment to the end of treatment at 12 months | Echocardiographic shunt flow velocity |
| Trans-shunt pressure gradient | From enrollment to the end of treatment at 12 months | Echocardiographic trans-shunt pressure gradient |
| Shunt flow direction | From enrollment to the end of treatment at 12 months | Echocardiographic shunt flow direction |
| Procedural Success Rates (Treatment Group) | 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. |
Countries
China
Contacts
CONTACTSanshuai Chang, M.D.
CONTACTGuangyuan Song, M.D.
PRINCIPAL_INVESTIGATORGuangyuan Song, M.D.
Beijing Anzhen Hospital
Outcome results
None listed