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LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07633535
Acronym
LVAD-INDEX
Enrollment
34
Registered
2026-06-08
Start date
2022-10-01
Completion date
2023-04-30
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

LVAD Index, Continuous-Flow Left Ventricular Assist Device, HVAD, HeartMate 3, Rehospitalization, Pump Flow

Brief summary

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.

Detailed description

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.

Interventions

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.

DEVICEHeartMate 3 Left Ventricular Assist 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.

Sponsors

Gaziantep City Hospital
Lead SponsorOTHER
Antalya City Hospital
CollaboratorOTHER
Akdeniz University Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Association Between LVAD Index and Selected Biochemical MarkersSix monthsThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026