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RECRUITING
NCT07053618
NA

Interventional Left Ventricular Assist System for PCI in CHIP Patients

Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD

View on ClinicalTrials.gov

Summary

Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years. In China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement. Common pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients. The aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for PCI.

Official title: Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

286

Start Date

2025-08-06

Completion Date

2027-08-01

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

DEVICE

Implantation of the VADLINK Percutaneous Left Ventricular Assist Device

To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).

DEVICE

VA-ECMO

Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.

Locations (15)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

People's Hospital of Hunan Province

Changsha, Hunan, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The People's Hospital of Liaoning Province

Shenyang, Liaining, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China