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

NCT07343102 | Completed

• 1 other identifier: 2025-2961
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemocompatibility-related Adverse Event

Keywords

hemocompatibility-related adverse event

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary endpoints were the individual components of the composite.

  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.

Study Arms (2)

Aspirin group

Aspirin group receiving the VKA and aspirin regimen after CH-VAD implantation.

Device: CH-VAD

Non-Aspirin group

Non-Aspirin group receiving the VKA without aspirin regimen after CH-VAD implantation.

Device: CH-VAD

Interventions

CH-VAD DEVICE

Patients who underwent CH-VAD implantation.

Aspirin group; Non-Aspirin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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) .

Sponsors & Collaborators

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

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 15, 2026
• Study Start: August 1, 2022
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)