NCT07382284 Long-Term Survival After LVAD Implantation in End-Stage Heart Failure
| NCT ID | NCT07382284 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | End-stage Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-07-17 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-07-17 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07382284 clinical trial?
This trial is open to participants of all sexes, studying End-stage Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07382284 currently recruiting?
Yes, NCT07382284 is actively recruiting participants. Contact the research team at pan_tuo@126.com for enrollment information.
Where is the NCT07382284 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07382284 clinical trial?
NCT07382284 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 300 participants.
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