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

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.

Study Overview

• Status: Recruiting
• Conditions: End-stage Heart Failure
• Intervention / Treatment: Other: Left Ventricular Assist Device (LVAD) implantation

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Tuo Pan, M.D; Phone Number: +86 15205160210; Email: pan_tuo@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • +86 025 83106666
      • Contact: Hai-Tao Zhang, M.D; Phone Number: +86 15210143301; Email: zhanght_pumc@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic and molecular correlates of clinical response after LVAD implantation	Genetic and molecular analyses will be performed using myocardial tissue obtained from the left ventricular apex during LVAD implantation and peripheral blood samples collected during routine clinical care. Genome-wide association analyses and expression quantitative trait locus (eQTL) analyses will be conducted to explore associations between genetic variation, gene expression profiles, and long-term clinical response after LVAD implantation. These analyses are exploratory and aim to characterize the biological background underlying heterogeneity in myocardial recovery among patients with end-stage heart failure.	Assessed during follow-up up to 3-5 years after LVAD implantation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dosage Forms; Delayed-Action Preparations; Drug Implants
• Other Study ID Numbers: 2024-577-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data, including genetic and molecular data generated from myocardial tissue and peripheral blood samples, will not be shared at this time due to ethical, legal, and regulatory considerations. In particular, the collection and use of human genetic data are subject to national regulations, and data sharing decisions will be evaluated after completion of data collection and analysis to ensure compliance with applicable laws and institutional policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No