End-stage Heart FailureLVAD-INDEXNCT07633535
LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients
An observational study of End-stage Heart Failure and Left Ventricular Assist Device, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Heart Failure, Left Ventricular Assist Device, Mechanical Circulatory Support
- What is being tested?
- HeartWare Ventricular Assist Device and HeartMate 3 Left Ventricular Assist Device
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Incomplete data
- Declined participation
- HeartMate II pump implantation
- Significant aortic valve dysfunction, including moderate or severe aortic regurgitation or stenosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Medicine
Antalya, 07070
About this study
Official 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
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.
Read the 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.
- Being tested
- HeartWare Ventricular Assist Device, HeartMate 3 Left Ventricular Assist Device
- Keywords
- LVAD Index, Continuous-Flow Left Ventricular Assist Device, HVAD, HeartMate 3, Rehospitalization, Pump Flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWare Ventricular Assist DeviceDevice
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 DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HVAD Group | Patients supported with the HeartWare Ventricular Assist Device. Receives: Device: HeartWare Ventricular Assist Device | |
| HeartMate 3 Group | Patients supported with the HeartMate 3 left ventricular assist device. Receives: Device: HeartMate 3 Left Ventricular Assist Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Oct 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Antalya City Hospital, Akdeniz University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633535
- Sponsor's protocol ID
- LVADIDX2022
- Acronym
- LVAD-INDEX
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to patient confidentiality and institutional data protection requirements. De-identified data may be made available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07633535
- Acronym / sponsor ID
- LVAD-INDEX / LVADIDX2022
- Keywords
- LVAD Index, Continuous-Flow Left Ventricular Assist Device, HVAD, HeartMate 3, Rehospitalization, Pump Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Collaborators
- Antalya City Hospital, Akdeniz University Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVAD Group | – | Device: HeartWare Ventricular Assist DevicePatients supported with the HeartWare Ventricular Assist Device. |
| HeartMate 3 Group | – | Device: HeartMate 3 Left Ventricular Assist DevicePatients supported with the HeartMate 3 left ventricular assist device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Incomplete data
- Declined participation
- HeartMate II pump implantation
- Significant aortic valve dysfunction, including moderate or severe aortic regurgitation or stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartWare Ventricular Assist DevicePatients 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. | Device | HVAD Group |
| HeartMate 3 Left Ventricular Assist DevicePatients 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. | Device | HeartMate 3 Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to patient confidentiality and institutional data protection requirements. De-identified data may be made available from the corresponding author upon reasonable request.
Related trials for End-stage Heart Failure
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Active, not recruitingPhase 3
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
RecruitingPhase 2/3
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
End Stage Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Heart Failure and Left Ventricular Assist Device, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between LVAD Index and Selected Biochemical Markers (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.