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NCT Number: NCT07255716

Postoperative Infections and Immune Profiles in Patients Undergoing LVAD Implantation

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.

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Key information

About this study

  • 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.
  • 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.

  • 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

  • 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.
  • Clinical examination data, including blood tests, imaging studies, cardiac function tests, etc.
  • 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.
  • 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.

  • 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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None intervention

Other

none intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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