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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04146727
Eligibility Criteria:
Inclusion Criteria:
Patients that are at high-risk patients for one of the following interventions, will be considered for this study:
1. Axillary impella patients awaiting transplant, advanced MCS therapy or weaning
2. MCS patients post procedure including TAH, LVADs
3. Lung Transplant patients
4. Subjects \> 18 years of age.
5. Ability to provide informed consent and follow-up with protocol procedures
Exclusion Criteria:
1. Non-ambulatory patients
2. Participation in an on-going protocol studying an experimental drug or device
3. Use of a walker, cane or wheelchair at baseline
4. Inability to wear the biosensor on the wrist
5. Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04146727
Study Brief:
Protocol Section:
NCT04146727