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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04539093
Eligibility Criteria:
Inclusion Criteria:
• Patients over the age of 18 years, deemed to be candidates for LVAD implantation. All ethnicities will be included in this study.
Exclusion Criteria:
* Age \< 18 years or \> 85 years.
* Presence of intra-cardiac shunt - safety concern for use of Echo contrast.
* Patient requiring temporary MCS - high acuity; may not be feasible to perform baseline assessment.
* Severe peripheral vascular disease - potential confounding bias during ultrasound assessment.
* Skeletal muscle disorder - not feasible to assess functional outcomes.
* Underlying/genetic vascular disease, i.e. vasculitis - potential for confounding bias during ultrasound assessment.
* Pregnant women - potential risk to fetus.
* Non-English Speaking.
* Active alcohol or illicit substance use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04539093
Study Brief:
Protocol Section:
NCT04539093