Incidence and Management of Driveline Infection in Patients with CH-VAD

March 10, 2025 updated by: Shengshou Hu, China National Center for Cardiovascular Diseases

Incidence and Management of Driveline Infection in Patients with CH-VAD: a Multi-centre, Observational Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

  1. Background: Driveline infection (DLI) is a major complication of left ventricular assist devices (LVADs) and is associated with significant morbidity and mortality. The CH-VAD is a novel, fully magnetically levitated LVAD designed with an ultra-thin and highly flexible driveline, which may reduce the risk of DLI compared to traditional LVADs. Previous research has indicated that driveline design features, such as diameter and flexibility, are key risk factors for DLI. This study aims to assess the incidence, management, outcomes and risk factors of DLI in CH-VAD patients.Rationale: Understanding the incidence and management of DLI in patients receiving the CH-VAD can provide valuable insights into the effectiveness of this device in reducing infection rates. A better understanding of these factors will help refine clinical practices and inform device development to minimize infection risks.

  2. Study Design

    • Design Type: Retrospective, observational, multicenter study.
    • Study Population: 181 consecutive patients who received CH-VAD implantations between June 2017 and October 2024 at 9 centers in China.
    • Primary Objective: To evaluate the incidence of DLI in CH-VAD patients.
    • Secondary Objectives: To identify factors associated with DLI, assess the management strategies, evaluate patient outcomes, and detect risk factors for DLI.

  3. Study Population

    • Inclusion Criteria:

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

      • Exclusion Criteria:

    • No specific exclusion criteria.

  4. Data Collection

    • Demographic and clinical characteristics from medical records, including age, sex, comorbidities, heart failure etiologies, INTERMACS profiles.
    • Surgical details, including device type, duration of support, and concomitant surgeries.
    • Infection prevention measures, including the use of prophylactic antibiotics, skin decolonization procedures, driveline fixation sutures, etc.
    • Driveline care measures, including dressing change frequency, types of disinfectants, dressing types, fixation measures, etc.
    • Incidence and management of DLI, including diagnostic methods, treatment approaches, and outcomes.
    • Information on the pathogens involved in DLI and complications such as recurrent infections, driveline revisions, and mortality.

  5. Statistical Analysis

    • Descriptive statistics will be used to summarize patient demographics, DLI incidence, and outcomes.
    • Univariate and multivariate regression analyses will be conducted to identify potential risk factors for DLI.
    • Time-to-event analysis will be performed using Kaplan-Meier curves to evaluate freedom from DLI over time.
    • Statistical significance will be set at p<0.05.

  6. Expected Outcomes and Significance

    • Primary Outcome: Incidence of DLI in patients with CH-VAD.
    • Secondary Outcomes: Risk factors associated with DLI, the impact of DLI on patient outcomes, and the effectiveness of different management strategies.
    • The findings from this study could provide valuable insights into the clinical management of CH-VAD patients and inform future advancements in LVAD design to minimize DLI.

  7. Timeline

    • Study Period: June 2017 to October 2024 (Data collection period).
    • Data Analysis Period: November 2024 to January 2025.
    • Results Publication: Expected by March 2025.

Study Type

Observational

Enrollment (Actual)

181

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No specific exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of driveline infection in CH-VAD patients in China
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Shanghai Zhongshan Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
Wuhan Asia Heart Hospital
Zhejiang Provincial People's Hospital
Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • China-NCCD

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

product manufactured in and exported from the U.S.

No

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.

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