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Recruiting NCT07382284

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

— Observational End-stage Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Left Ventricular Assist Device (LVAD) implantation.
Who it may be relevant to
Registry conditions: End-stage Heart Failure. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Left 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.

Primary outcome measures

  • Clinical response after LVAD implantation [Time frame: During longitudinal follow-up up to 5 years after LVAD implantation]
Secondary outcome measures (1)
  • Genetic and molecular correlates of clinical response after LVAD implantation [Time frame: Assessed during follow-up up to 3-5 years after LVAD implantation]

Eligibility criteria

Inclusion criteria

  • 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
  • Willing and able to comply with study procedures and long-term follow-up
  • Availability of left ventricular apical myocardial tissue obtained during LVAD implantation surgery
  • Availability of peripheral blood samples collected during routine clinical care
  • Patients treated at participating study centers

Exclusion criteria

  • 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
  • Active systemic infection or sepsis at the time of LVAD implantation
  • Known active malignancy with a life expectancy <1 year
  • Severe non-cardiac comorbidities limiting expected survival to less than 1 year (e.g., advanced liver failure, end-stage renal disease not eligible for renal replacement therapy)
  • Inability or unwillingness to provide informed consent
  • Pregnancy or breastfeeding at the time of enrollment
  • Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • +86 025 83106666 — Nanjing

Publications

  • Drakos SG, Badolia R, Makaju A, Kyriakopoulos CP, Wever-Pinzon O, Tracy CM, Bakhtina A, Bia R, Parnell T, Taleb I, Ramadurai DKA, Navankasattusas S, Dranow E, Hanff TC, Tseliou E, Shankar TS, Visker J, Hamouche R, Stauder EL, Caine WT, Alharethi R, Selzman CH, Franklin S. Distinct Transcriptomic and Proteomic Profile Specifies Patients Who Have Heart Failure With Potential of Myocardial Recovery o PMID 36448446

Identifiers

NCT: NCT07382284 · 2024-577-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗