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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemocompatibility-related Adverse Event
• Intervention / Treatment: Device: CH-VAD

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent CH-VAD implantation in 13 participating centers during the study period.

Description

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) .

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aspirin group; Aspirin group receiving the VKA and aspirin regimen after CH-VAD implantation.	Device: CH-VAD; Patients who underwent CH-VAD implantation.
Non-Aspirin group; Non-Aspirin group receiving the VKA without aspirin regimen after CH-VAD implantation.	Device: CH-VAD; Patients who underwent CH-VAD implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint was survival free from non-surgical HRAEs at 12 months, estimated using Kaplan-Meier methods.	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints were the individual components of the composite.	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.	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.

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Shanghai Zhongshan Hospital; First Affiliated Hospital Xi'an Jiaotong University; Ruijin Hospital; First Affiliated Hospital of Zhejiang University; Sir Run Run Shaw Hospital; Wuhan Asia Heart Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; Zhejiang Provincial People's Hospital; Sichuan Provincial People's Hospital; Second Hospital of Jilin University; Jiangsu Provincial People's Hospital; Henan Provincial Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): November 20, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: hemocompatibility-related adverse event
• Other Study ID Numbers: 2025-2961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No