Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction

NCT07820410 | Recruiting Phase 2 DMC

• 1 other identifier: BeijingAnzhen20260716
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Keywords

Heart Failure with Reduced Ejection Fraction; Atrial shunt

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (24)

• 6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）

  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）

  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

  From enrollment to the end of treatment at 12 months

• Device Success Rates (Treatment Group)

  From enrollment to the end of treatment at 12 months

Other Outcomes (1)

• Device-Related Adverse Events

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Device group (Interventional group)

EXPERIMENTAL

Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease

Device: D-shant Atrial Shunt; Drug: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction

no Device group (Control Group)

ACTIVE COMPARATOR

Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only

Drug: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction

Interventions

D-shant Atrial Shunt DEVICE

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.

Device group (Interventional group)

Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction DRUG

Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction

Device group (Interventional group); no Device group (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Study Officials

• Guangyuan Song, M.D.

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanshuai Chang, M.D.

CONTACT

+8618501369869; 18501369869@163.com

Guangyuan Song, M.D.

CONTACT

+8613801120805; songgy_anzhen@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of interventional center of valvular heart disease

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: September 15, 2026
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

CN (1)