Postoperative Infections and Immune Profiles in Patients Undergoing LVAD Implantation

November 20, 2025 updated by: China National Center for Cardiovascular Diseases
The objective of this study is to investigate the incidence of infection and changes in the immune profile following left ventricular assist device implantation. The primary aim is to elucidate the relationship between postoperative infection and immune alterations and to identify risk factors predictive of postoperative infection.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Background: left ventricular assist devices (LVADs) implantation is an important treatment for end-stage heart failure. Previous studies have indicated that implantation of a left ventricular assist device may alter a patient's immune status by affecting immune cells, which may be a significant reason for the high postoperative infection rate among patients. Previous studies have indicated that left ventricular assist device implantation may alter patients' immune status by affecting immune cells, which may be a significant factor contributing to high postoperative infection rates. The aim of this study is to evaluate infection events following LVAD implantation and their relationship with patients' immune status. this will be crucial for predicting infection occurrence and identifying potential intervention strategies.

  2. Study design:

    Design Type: Retrospective, observational, multi-center study Study Population: patients who received LVAD implantations between June 2020 and October 2025 at 2 centers in China.

    Primary Objective: To evaluate the incidence of infection rate after LVAD implantation .

    Secondary Objectives: To identify factors associated with infection, assess the immune status alteration after LVAD implantation.

  3. Study Population Inclusion criteria (i) age >18 years, (ii) indication for LVAD implantation, (iii)informed consent.

Exclusive criteria included active preoperative infection and no other circulatory support devices were used preoperatively

4. Data Collection

  1. Demographic and clinical characteristics from medical records, including age, sex, comorbidities, heart failure etiologies, INTERMACS profiles.
  2. Surgical details, including device type, duration of support, and concomitant surgeries.
  3. Infection prevention measures, including the use of prophylactic antibiotics, skin decolonization procedures, driveline fixation sutures, etc.
  4. Clinical examination data, including blood tests, imaging studies, cardiac function tests, etc.
  5. Regular follow-up data, including clinical blood tests, changes in cardiac function, and incidence of infection events, along with collection of peripheral blood for assessment of immune status.

5. Statistical Analysis Descriptive statistics will be used to summarize patient demographics, infection incidence, and outcomes. Subgroup analyses will be conducted based on the types of postoperative infections.

Longitudinal clinical examination data were analyzed using longitudinal linear mixed models, with appropriate post-hoc comparisons via the emmeans package, applying Bonferroni adjustment for multiple testing.

Statistical significance will be indicated by the specific p-values for each comparison.

6. Expected Outcomes and Significance Primary Outcome: Incidence of different types of infections after LVAD implantation.

Secondary Outcomes: the longitudinal changes in immune indicators after LVAD implantation and the association between infection incidence and immune status.

The findings of this study may offer guidance for the clinical management of postoperative infections and support the development of potential intervention strategies.

7. Timeline Study Period: June 2020 to October 2025 Data Analysis Period: November 2024 to January 2025

Study Type

Observational

Enrollment (Estimated)

120

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
    • Xicheng
      • Beijing, Xicheng, 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

Patients receiving LVAD implantation who meet the inclusion criteria

Description

Inclusion Criteria:

(i) age >18 years, (ii) indication for LVAD implantation, (iii)informed consent.

Exclusion Criteria:

(i) active preoperative infection (ii) other circulatory support devices were used preoperatively

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group1: All patients who met the inclusion criteria for LVAD implantation
Other: none intervention
none intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
culture-proven infections
Time Frame: Infection confirmed within 90 days postoperatively is defined as early infection; infection confirmed after 90 days postoperatively is defined as late infection.
Infection confirmed within 90 days postoperatively is defined as early infection; infection confirmed after 90 days postoperatively is defined as late infection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immune parameters changes after LVAD implantation.
Time Frame: Blood test results available at various follow-up intervals from preoperative to postoperative periods, including 2 weeks, 1 month, 3 months, 6 months, etc.
the longitudinal changes in clinical and immune parameters after LVAD implantation
Blood test results available at various follow-up intervals from preoperative to postoperative periods, including 2 weeks, 1 month, 3 months, 6 months, etc.

Collaborators and Investigators

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

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Chinese Academy of Medical Sciences, Fuwai 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, 2020

Primary Completion (Actual)

November 15, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023CXGC011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Pneumonia

Clinical Trials on none intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe