LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients

NCT07633535 | Completed

• 1 other identifier: LVADIDX2022
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Association Between LVAD Index and Selected Biochemical Markers

  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.

  Six months

Study Arms (2)

HVAD Group

Patients supported with the HeartWare Ventricular Assist Device.

Device: HeartWare Ventricular Assist Device

HeartMate 3 Group

Patients supported with the HeartMate 3 left ventricular assist device.

Device: HeartMate 3 Left Ventricular Assist Device

Interventions

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.

HVAD Group

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.

HeartMate 3 Group

Eligibility Criteria

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

Study Population

Adult patients with end-stage heart failure who underwent first-time continuous-flow left ventricular assist device implantation and were followed for at least six months. The study population included patients supported with either HVAD or HeartMate 3 devices during routine clinical follow-up.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziantep City Hospital: lead
• Antalya City Hospital: collaborator
• Akdeniz University Hospital: collaborator

Study Sites (1)

Akdeniz University Faculty of Medicine

Antalya, 07070, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: October 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)