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.
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
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
The study population consists of adult patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation as part of routine clinical care. Participants are primarily enrolled from Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhejiang University School of Medicine; and The First Affiliated Hospital of Harbin Medical University. A smaller number of patients are also enrolled from Jinan Central Hospital and the Affiliated Hospital of Yangzhou University. All participating centers are tertiary referral hospitals with established LVAD programs.
Cohort
Prospective
Left Ventricular Assist Device (LVAD) implantation
Other interventionLeft ventricular assist device (LVAD) implantation performed as part of routine clinical care for patients with end-stage heart failure. This study is observational in nature and does not assign, alter, or mandate any intervention. The decision to implant an LVAD, the type of device used, perioperative management, and postoperative treatment are determined solely by the treating clinical team according to standard clinical practice.
Clinical response after LVAD implantation
Patients will be classified as responders or non-responders based on predefined criteria.
Genetic and molecular correlates of clinical response after LVAD implantation
Genetic and molecular analyses will be performed using myocardial tissue obtained from the left ventricular apex during LVAD implantation and peripheral blood samples collected during routine clinical care. Genome-wide association analyses and expression quantitative trait locus (eQTL) analyses will be conducted to explore associations between genetic variation, gene expression profiles, and long-term clinical response after LVAD implantation. These analyses are exploratory and aim to characterize the biological background underlying heterogeneity in myocardial recovery among patients with end-stage heart failure.
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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
