NCT07233876

DuoCor 2 DOMINATE Study

A Prospective, Multi-Center, Single-Arm Study for the Evaluation of the DuOCor 2 Ventricular Assist SysteM In Patients With AdvaNced BIventriCulAr HearT FailurE

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shenzhen Core Medical Technology CO.,LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation. In such cases, medical treatments often prove ineffective, necessitating advanced treatment. Heart transplantation is the standard treatment for these patients, but it is severely limited by the shortage of donor hearts. As a result, mechanical circulatory support (MCS) devices are often employed. However, the most common form, the left ventricular assist device (LVAD), is only suitable for patients with isolated left ventricular dysfunction. This leaves a significant treatment gap for patients with biventricular failure. For this population, current options, such as total artificial hearts (TAHs) and biventricular assist devices (BiVADs), are associated with significant challenges, including high rates of adverse events and suboptimal long-term outcomes. The DuoCor Ventricular Assist System (VAS) is a next-generation MCS device specifically developed to address this need by providing simultaneous biventricular support. It incorporates two compact, good hemocompatible blood pumps designed for implantation in both the left and right heart, controlled via a single driveline and external controller. It aims to reduce surgical complexity, improve patient mobility, and minimize complications such as thrombosis and infection. The primary objective of this study is to evaluate the safety and efficacy of the DuoCor VAS as a treatment for advanced biventricular heart failure.

Conditions

• Advanced Heart Failure

Interventions

Type	Name	Description
DEVICE	DuoCor Ventricular Assist System	Implantation of the DuoCor Ventricular Assist System for mechanical circulatory support.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2029-04-01
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Germany