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Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
Sponsor: Beijing Anzhen Hospital
Summary
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)
Official title: A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2024-11-25
Completion Date
2027-12-31
Last Updated
2026-09-15
Healthy Volunteers
No
Interventions
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.
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
Locations (1)
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
Beijing, Beijing Municipality, China