Long-term outcomes after LVAD implantation for 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
We will follow adults with end-stage heart failure who get an LVAD to see if they live longer and to record complications and hospital visits over the next 3–5 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07382284 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, multicenter cohort enrolling adults with end-stage heart failure who undergo LVAD implantation as part of routine care. Investigators will collect baseline, preoperative, intraoperative, and in-hospital information and then track postoperative medications, survival status, major clinical events, LVAD-related complications, and hospital readmissions for 3–5 years. Left ventricular apical myocardial tissue (routinely removed during surgery) and peripheral blood samples collected during clinical care will be banked for future molecular and pathologic analyses. No experimental treatments are given; the goal is to describe real-world long-term outcomes and identify factors associated with survival and complications.
Who should consider this trial
Good fit: Adults (≥18) with end-stage heart failure refractory to optimal medical therapy who are scheduled for LVAD implantation at a participating center and can provide informed consent and biospecimens are eligible.
Not a fit: Patients under 18, those with prior durable mechanical circulatory support, concurrent heart transplantation at the time of surgery, complex congenital heart disease, active systemic infection or sepsis, or a known active malignancy with life expectancy under one year are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could help doctors predict which patients do best after an LVAD and guide long-term care to reduce complications and hospital stays.
How similar studies have performed: Large registries and observational cohorts have documented LVAD survival and complication patterns, but prospective multicenter cohorts that include routine myocardial tissue banking are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged ≥18 years 2. Diagnosis of end-stage heart failure refractory to optimal medical therapy 3. Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care 4. Able to provide written informed consent for participation and biospecimen collection 5. Willing and able to comply with study procedures and long-term follow-up 6. Availability of left ventricular apical myocardial tissue obtained during LVAD implantation surgery 7. Availability of peripheral blood samples collected during routine clinical care 8. Patients treated at participating study centers Exclusion Criteria: 1. Age \<18 years 2. Prior implantation of a durable mechanical circulatory support device 3. Concomitant heart transplantation at the time of index surgery 4. Congenital heart disease requiring complex surgical repair 5. Active systemic infection or sepsis at the time of LVAD implantation 6. Known active malignancy with a life expectancy \<1 year 7. 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) 8. Inability or unwillingness to provide informed consent 9. Pregnancy or breastfeeding at the time of enrollment 10. Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses
Where this trial is running
Nanjing, Jiangsu
- +86 025 83106666 — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Tuo Pan, M.D
- Email: pan_tuo@126.com
- Phone: +86 15205160210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.