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NCT Number: NCT07633535

LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients

This single-center, observational study evaluated the LVAD index, defined as device-estimated pump flow divided by body surface area, in adult patients supported with continuous-flow left ventricular assist devices. The study included 34 patients with end-stage heart failure who had either an HVAD or HeartMate 3 device and were followed for six months. The study assessed the relationship between LVAD index and selected routine biochemical markers related to hepatic and renal status, including ALT, AST, LDH, BUN, and creatinine. The study also evaluated whether LVAD index was associated with rehospitalization during follow-up.

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Key information

Conditions

End-stage Heart Failure Left Ventricular Assist Device Mechanical Circulatory Support

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University Faculty of Medicine

Antalya, 07070, Turkey (Türkiye)

About this study

This observational cohort study included adult patients with end-stage heart failure supported with continuous-flow left ventricular assist devices. Patients with HVAD and HeartMate 3 devices were followed during routine clinical visits over a six-month period. Device-estimated pump flow, power consumption, and LVAD index were recorded at follow-up visits. LVAD index was calculated as device-estimated pump flow divided by body surface area. Routine laboratory parameters, including ALT, AST, LDH, BUN, and creatinine, were evaluated as selected biochemical markers related to hepatic and renal status and tissue injury. Rehospitalization status during follow-up was also assessed. The study did not assign participants to any intervention and did not include protocol-driven pump speed adjustment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Diagnosis of end-stage heart failure
  • First-time continuous-flow left ventricular assist device implantation
  • Implanted with either an HVAD or HeartMate 3 left ventricular assist device
  • Minimum follow-up period of six months

Exclusion criteria

  • Incomplete data
  • Declined participation
  • HeartMate II pump implantation
  • Significant aortic valve dysfunction, including moderate or severe aortic regurgitation or stenosis

Treatment and study plan

HeartWare Ventricular Assist Device

Device

Patients in this group were supported with the HeartWare Ventricular Assist Device as part of routine clinical care. No device assignment or protocol-driven intervention was performed by the study investigators.

HeartMate 3 Left Ventricular Assist Device

Device

Patients in this group were supported with the HeartMate 3 left ventricular assist device as part of routine clinical care. No device assignment or protocol-driven intervention was performed by the study investigators.

Primary outcomes

  1. Association Between LVAD Index and Selected Biochemical Markers

    Time frame: Six months

    The association between LVAD index and selected routine biochemical markers, including ALT, AST, LDH, BUN, and creatinine, was evaluated during six-month follow-up. LVAD index was calculated as device-estimated pump flow divided by body surface area.

Sponsors and collaborators

Lead sponsor

Gaziantep City Hospital

Other

Collaborators

  • Akdeniz University Hospital
  • Antalya City Hospital

Registry information

Official study title

Association of LVAD Index With Selected Hepatic and Renal Biochemical Markers and Rehospitalization in HVAD and HeartMate 3 Continuous-Flow Left Ventricular Assist Devices

Acronym: LVAD-INDEX

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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