Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT00534703
Eligibility Criteria:
Inclusion criteria
* Patients that have had a left ventricular assist device (LVAD) implanted for chronic heart failure, where chronic heart failure is defined as at least 6 months
* Patients are clinically stable in the opinion of the clinical team looking after the patient
* Written informed consent
Exclusion criteria
* \<18 or \>70 years of age at the time of consent
* Pregnancy or within 6 months of giving birth
* Women of child-bearing potential not using an effective method of contraception
* Men not using an effective method of contraception
* Suspected or active viral, fungal or parasitic infection within 48 hours prior to administration of IMP, in the opinion of the investigator\*.
* Patients at a high risk of thrombosis in the opinion of the investigator
* Patients with a previous episode of LVAD thrombosis
* Patients with persistently raised lactate dehydrogenase (LDH \>2.5 ULN)
* Patients requiring triple anticoagulation i.e. warfarin and dual anti-platelet
* Patients participating in another clinical trial
* Patients unable to comply with the protocol mandated procedures for social or other reasons, in the opinion of the investigator and primary care physician
* Eligible, enrolled and randomised patients who develop an infection will have study treatment delayed until 7 or more days after the time point when infection is no longer clinically evident.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00534703
Study Brief:
Protocol Section:
NCT00534703