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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03044535
Eligibility Criteria:
Group 1 Inclusion Criteria
1. Advanced heart failure patients accepted for, or scheduled for, primary (first time) implant of a continuous flow MCS device left (L)VAD
2. The continuous flow MCS device implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
3. Age \>= 19 years and able to speak and understand English
4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance.
5. Willing to participate and able to give written informed consent
Group 1 Exclusion Criteria:
1\. Scheduled for implant of a bi-VAD, right (R)VAD, or total artificial heart
Group 2 Inclusion Criteria:
1. Patient with a continuous flow MCS device left (L)VAD who is more than 3 months post-implant at the following intervals: 3, 6, 12, 18, 24, 30, 36, 42, 48 months and every 6 months thereafter. Note: patients can have had prior MCS devices.
2. The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
3. Age \>= 19 years and able to speak and understand English
4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance
5. Willing to participate and able to give written informed consent
Group 2 Exclusion Criteria:
1\. Has a bi-VAD, right (R)VAD, or total artificial heart
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03044535
Study Brief:
Protocol Section:
NCT03044535