Long-Term Survival After LVAD Implantation in End-Stage Heart Failure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.

Patients receiving LVAD implantation as part of routine clinical care will be enrolled and followed for up to 3-5 years. During the study period, data will be collected on baseline characteristics, preoperative medical therapy, intraoperative surgical information, in-hospital course, and long-term postoperative medication use, as well as survival status, major clinical outcomes, LVAD-related complications, and hospital readmissions.

In addition, myocardial tissue samples will be obtained from the left ventricular apex during LVAD implantation surgery. These tissue samples are routinely removed as part of the standard surgical procedure and would otherwise be discarded after pathological examination. Peripheral blood samples will also be collected at predefined time points as part of routine clinical blood testing. No additional surgical procedures or invasive interventions are required for this study.

This study does not involve any experimental treatment or changes to standard medical care. All treatments and follow-up assessments are determined by the treating physicians according to routine clinical practice.

The purpose of this study is to improve understanding of long-term outcomes after LVAD implantation and to explore potential biological factors associated with prognosis in patients with end-stage heart failure.

Eligibility criteria

Qualifiers

Adults aged ≥18 years

Diagnosis of end-stage heart failure refractory to optimal medical therapy

Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care

Able to provide written informed consent for participation and biospecimen collection

Disqualifiers

Age <18 years

Prior implantation of a durable mechanical circulatory support device

Concomitant heart transplantation at the time of index surgery

Congenital heart disease requiring complex surgical repair

Trial design

Treatments tested in this trial

  • Left Ventricular Assist Device (LVAD) implantation

Treatment groups

No treatment groups listed

Sponsors and collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

First Affiliated Hospital of Harbin Medical University

Collaborator

Yangzhou University

Collaborator

Qianfoshan Hospital

Collaborator

Xinhua Hospital of Ili Kazak Autonomous Prefecture

Collaborator

Zhejiang University

Collaborator