Skip to main content
OpenTrials
Completed

NCT Number: NCT07343102

Incidence of Hemocompatibility Events With or Without Aspirin in Patients With CH-VAD

The goal of this observational study is to investigate the impact of oral warfarin anticoagulation combined with or without aspirin on the incidence of non-surgical hemocompatibility-related adverse events (HRAEs) and survival in advanced heart failure patients after implantation of the fully magnetic levitation left ventricular assist device (CH-VAD).

The main question it aims to answer is : The incidence of non-surgical HRAEs and survival treated with oral warfarin anticoagulation combined with or without aspirin in Chinese CH-VAD implanted advanced heart failure patients.

CH-VAD has been approved in China for the treatment of patients with advanced heart failure.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, China

About this study

This was a multi-center, retrospective observational study including patients who underwent CH-VAD implantation in 13 participating centers after its commercial approval, from Aug 2022 through Aug 2025. Patients who died during the index hospitalization were excluded. Patients whose antiplatelet regimen was modified before the occurrence of the first non-surgical hemocompatibility-related adverse event (HRAE) were also excluded to avoid exposure misclassification. Patients were divided into two groups: those receiving aspirin in addition to warfarin (ASA+VKA) versus those receiving warfarin alone (VKA only). Warfarin was started once the patient was clinically stable and able to tolerate oral medication, with a target international normalized ratio (INR) of 2.0-2.5. For patients receiving aspirin, the dose was 100 mg daily.

The primary endpoint was a composite of survival free of major nonsurgical HRAEs at 12 months. Nonsurgical events were defined as any event occurring > 14-days post implant to avoid perioperative confounding. The composite endpoint was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent CH-VAD implantation in 13 participating centers after its commercial approval, from Aug 2022 through Aug 2025.

Exclusion criteria

  • Patients who died during the index hospitalization.
  • Patients whose antiplatelet regimen was modified before the occurrence of the first non-surgical hemocompatibility-related adverse event (HRAE) .

Treatment and study plan

CH-VAD

Device

Patients who underwent CH-VAD implantation.

Primary outcomes

  1. The primary endpoint was survival free from non-surgical HRAEs at 12 months, estimated using Kaplan-Meier methods.

    Time frame: Reported data includes the period from 14-days post implant to study completion. Outcome measurement is performed at the study completion, a median follow-up of 368 days.

    The composite endpoint was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism. Nonsurgical events were defined as any event occurring > 14-days post implant to avoid perioperative confounding.

Secondary outcomes

  1. Secondary endpoints were the individual components of the composite.

    Time frame: Reported data includes the period from 14-days post implant to study completion. Outcome measurement is performed at the study completion, a median follow-up of 368 days.

    The composite was comprised of stroke, pump thrombosis, major nonsurgical bleeding, and peripheral arterial thromboembolism. Nonsurgical events were defined as any event occurring > 14-days post implant to avoid perioperative confounding.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Zhejiang University
  • Henan Provincial Chest Hospital
  • Jiangsu Provincial People's Hospital
  • Ruijin Hospital
  • Second Hospital of Jilin University
  • Shanghai Zhongshan Hospital
  • Sichuan Provincial People's Hospital
  • Sir Run Run Shaw Hospital
  • Wuhan Asia Heart Hospital
  • Zhejiang Provincial People's Hospital

Registry information

Official study title

Incidence of Hemocompatibility Events With or Without Aspirin in Patients With CH-VAD: a Multi-centre, Observational Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.