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NCT07382284Recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
25 Jan 2026
Start date
17 Jul 2022
Primary completion date
1 Aug 2028
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT number
NCT07382284

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 17 Jul 2022 to the primary completion date, 1 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior implantation of a durable mechanical circulatory support device
  • Concomitant heart transplantation at the time of index surgery

Other illness

  • 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)
  • Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses

Age

  • Age \<18 years

Other

  • Inability or unwillingness to provide informed consent
  • Pregnancy or breastfeeding at the time of enrollment

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
+86 025 83106666
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NanjingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.