Atrial Shunt to Help Heart Failure With Reduced Ejection Fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label study comparing an atrial shunt implant plus guideline-directed medical therapy (GDMT) to GDMT alone in adults with HFrEF. Participants are randomized 1:1 after screening and will be followed for 12 months with visits at baseline, procedure day, 1 week, 1 month, 3 months, 6 months, and 12 months. A Clinical Event Committee will independently adjudicate primary endpoints in a blinded fashion. The study aims to determine if the shunt improves clinical outcomes compared with standard care, using predefined safety and effectiveness measures.

Why it matters

Who can join: the full rules

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

Where it's running

• Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Guangyuan Song, M.D. — Beijing Anzhen Hospital
• Study coordinator: Sanshuai Chang, M.D.
• Email: 18501369869@163.com
• Phone: +8618501369869

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Achieving Optimal Medical Therapy Through Transcatheter Mitral Repair in HFrEF

  This trial tests whether early transcatheter edge-to-edge repair (M-TEER) helps patients with HFrEF and secondary MR reach guideline-directed medical therapy faster and more completely, and whether that improves quality of life and outcomes.

  Recruiting University Medical Center Mainz · Mainz, Rhineland-Palatine · NCT07758023

• CRD-4730 for heart failure with reduced ejection fraction

  This trial tests CRD-4730 versus placebo to see if it helps adults with HFrEF who are already on standard heart failure therapy.

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• Olive oil supplementation during cardiac rehab for heart failure with reduced ejection fraction

  This study tests whether adding extra-virgin olive oil during a cardiac rehabilitation program is doable and helpful for people with HFrEF.

  Recruiting Old Dominion University · Norfolk, Virginia · NCT07644806

• Remote-guided medication up-titration for people with reduced ejection fraction heart failure

  This trial will see if telemedicine follow-up helps clinicians start and increase guideline-recommended heart failure medicines faster and more completely in adults with newly diagnosed HFrEF.

  Recruiting Azienda Unita Sanitaria Locale di Piacenza · Piacenza · NCT07518030

• Vericiguat for right‑ventricular function and heart remodeling in HFrEF

  This study will test whether adding vericiguat to usual heart‑failure treatment helps adults with stable HFrEF improve right‑ventricular function and heart remodeling over 12 months.

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• Nerve ablation for heart failure with reduced ejection fraction using the right greater splanchnic nerve

  This early-stage, catheter-based test looks at whether ablating the right greater splanchnic nerve can help people 40 and older with HFrEF and is done in a randomized, sham-controlled setup.

  Recruiting at 7 sites Axon Therapies, Inc. · Prague and 8 other locations · NCT07403058

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.