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RECRUITING
NCT07820410
PHASE2/PHASE3

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

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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

DEVICE

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.

DRUG

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