Postoperative Infections and Immune Profiles in Patients Undergoing LVAD Implantation

NCT07255716 | Active Not Recruiting

• 1 other identifier: 2023CXGC011
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection; Driveline Heart-assisted Device Related Infection; Pneumonia; Sepsis

Keywords

lvad; infection

Outcome Measures

Primary Outcomes (1)

• culture-proven infections

  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.

  Blood test results available at various follow-up intervals from preoperative to postoperative periods, including 2 weeks, 1 month, 3 months, 6 months, etc.

Study Arms (1)

group1: All patients who met the inclusion criteria for LVAD implantation

Other: none intervention

Interventions

none intervention OTHER

none intervention

group1: All patients who met the inclusion criteria for LVAD implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving LVAD implantation who meet the inclusion criteria

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Fuwai Hospital

Beijing, Xicheng, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples retained for flow cytometry and single-cell RNA sequencing.

MeSH Terms

Conditions

Infections; Pneumonia; Sepsis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: June 1, 2020
• Primary Completion: November 15, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (1)