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

NCT07382284 | Recruiting

• 1 other identifier: 2024-577-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Heart Failure

Outcome Measures

Primary Outcomes (1)

• Clinical response after LVAD implantation

  Patients will be classified as responders or non-responders based on predefined criteria.

  During longitudinal follow-up up to 5 years after LVAD implantation

Secondary Outcomes (1)

• Genetic and molecular correlates of clinical response after LVAD implantation

  Assessed during follow-up up to 3-5 years after LVAD implantation

Interventions

Left Ventricular Assist Device (LVAD) implantation OTHER

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.

Also known as: Mechanical circulatory support implantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation as part of routine clinical care. Participants are primarily enrolled from Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhejiang University School of Medicine; and The First Affiliated Hospital of Harbin Medical University. A smaller number of patients are also enrolled from Jinan Central Hospital and the Affiliated Hospital of Yangzhou University. All participating centers are tertiary referral hospitals with established LVAD programs.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: collaborator
• The Affiliated Hospital of Yangzhou University: collaborator
• Qianfoshan Hospital: collaborator
• Xinhua Hospital of Ili Kazak Autonomous Prefecture: collaborator
• Zhejiang University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

+86 025 83106666

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• 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 on Mechanical Unloading and Circulatory Support. Circulation. 2023 Jan 31;147(5):409-424. doi: 10.1161/CIRCULATIONAHA.121.056600. Epub 2022 Nov 30.

  PMID: 36448446 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Myocardial tissue samples obtained from the left ventricular apex during LVAD implantation surgery, which are routinely removed as part of standard surgical care and would otherwise be discarded after pathological examination, will be retained. Peripheral blood samples obtained from routine clinical blood testing will also be retained for research analyses.

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Tuo Pan, M.D

CONTACT

+86 15205160210; pan_tuo@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: July 17, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)