NCT06878456

Brief Summary

The goal of this observational study is to learn about the incidence of the Driveline Infection of a novel full-magnetically levitated left ventricular assist device with a new design of driveline. The main question it aims to answer is : The incidence of DLI in Chinese CH-VAD implanted advanced heart failure patients and the main risk factors. CH-VAD has been approved in China for the treatment of patients with advanced heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

7.4 years

First QC Date

January 13, 2025

Last Update Submit

March 10, 2025

Conditions

Driveline Infection

Keywords

advanced heart failureleft ventricular assist devicedriveline infection

Outcome Measures

Primary Outcomes (1)

  • the incidence of driveline infection in CH-VAD patients in China

    Reported data includes baseline, peri-operative data and data at study completion. Outcome measurement is performed at the study completion, an average of 1.03 years.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

181 consecutive AHF patients who received CH-VAD implantation between June 2017 and October 2024 in China, with no patients excluded.

You may qualify if:

  • Patients who received CH-VAD implantations for advanced heart failure between June 2017 and October 2024.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Wang X, Zhou X, Chen H, Zhang H, Zhang Y, Cui Y, Huang K, Hua Z, Yan Y, Zhou M, Zhao Q, Sun X, Wang C, Ge Z, Dong A, Hu S. Low Driveline Infection Rates in Patients With a Novel Fully Magnetically Levitated Ventricular Assist Device. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf365. doi: 10.1093/ejcts/ezaf365.

    PMID: 41137667DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academician of Chinese Academy of Engineering

Study Record Dates

First Submitted

January 13, 2025

First Posted

March 17, 2025

Study Start

June 1, 2017

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)