Postoperative infections after LVAD implantation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 or older at the time of implantation. 2. First-time implantation of a Heartmate 3 LVAD. 3. Implantation period: November 2025 through November 2025.
Exclusion criteria
Exclusion criteria: 1. Secondary implantation of an HM3-type LVAD as part of a revision procedure involving device replacement from another model to an HM3. 2. Primary implantation of an HM3 as a permanent BiVAD or RVAD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall five-year survival rate after first-time implantation of a Heartmate 3 LVAD. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival rate after initial Heartmate 3 LVAD implantation at 90 days, one year and two years. 2. Five-year survival rate free of late-onset MCS-specific infection more than 90 days after LVAD-implantation. 3. Incidence rate and cumulative incidence of MCS-specific and non-MCS-specific infections until postoperative day 90 after LVAD implantation. 4. Incidence rates and cumulative incidences of the non-infectious adverse events bleeding, neurologic dysfunction, device malfunction, hemolysis, right heart failure, renal dysfunction, cardiac arrhythmias, respiratory failure, venous thromboembolism, wound dehiscence and arterial non-CNS thromboembolism. | — |
Countries
Germany
Contacts
Universitätsinstitut für Medizinische Mikrobiologie und Virologie, Klinikum Oldenburg AöR