RecruitingNCT07382284

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

Long-Term Survival After Left Ventricular Assist Device Support (LVAD) Implantation in Patients With End-Stage Heart Failure: A Prospective, Observational, Multi-Center Cohort Study


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

300 participants

Start Date

Jul 17, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Plain Language Summary

Simplified for easier understanding

This study is looking at long-term survival in people with end-stage heart failure who receive a left ventricular assist device (LVAD) — a pump surgically implanted to help the heart push blood through the body. Researchers will analyze heart tissue and blood samples to find biological markers that predict how well patients do after the surgery. **You may be eligible if...** - You are 18 years or older - You have end-stage heart failure that hasn't responded to medications - You are already scheduled to receive an LVAD as part of your regular medical care - You are willing to participate in long-term follow-up and allow tissue and blood sample collection **You may NOT be eligible if...** - You previously had a long-term mechanical heart pump implanted - You are having a heart transplant at the same time as LVAD surgery - You have congenital heart disease needing complex surgery - You have an active infection or sepsis at the time of surgery - You have an active cancer with less than one year life expectancy - You have severe non-heart-related illness limiting survival to under one year - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLeft Ventricular Assist Device (LVAD) implantation

Left 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.


Locations(1)

+86 025 83106666

Nanjing, Jiangsu, China

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NCT07382284


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