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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- Fuwai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Aspirin group
Aspirin group receiving the VKA and aspirin regimen after CH-VAD implantation.
|
Patients who underwent CH-VAD implantation.
|
|
Non-Aspirin group
Non-Aspirin group receiving the VKA without aspirin regimen after CH-VAD implantation.
|
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.
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.
|
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.
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.
|
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-2961
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.