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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
+86 025 83106666
RECRUITING
Nanjing
Contact Information
Primary
Tuo Pan, M.D
pan_tuo@126.com
+86 15205160210
Time Frame
Start Date: 2022-07-17
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 300
Related Therapeutic Areas
Sponsors
Collaborators: Xinhua Hospital of Ili Kazak Autonomous Prefecture, Zhejiang University, The Affiliated Hospital of Yangzhou University, First Affiliated Hospital of Harbin Medical University, Qianfoshan Hospital
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov