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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04199793
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Approved for or supported with HeartWare durable LVAD
3. Capable of giving informed consent
Exclusion Criteria:
1. For those undergoing new device implantation:
1. Age \<18 years
2. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 at the time of implantation
3. Presence of intra-cardiac thrombus
4. History of thromboembolic event within previous 3 months of enrollment
2. For those with prior LVAD implantation with on-going support:
1. Support duration \<3 months
2. History of prior LVAD pump exchange
3. History of LVAD pump hemolysis or thrombosis as defined by INTERMACS criteria
4. History of stroke or transient ischemic event within previous 3 months of enrollment
5. History of post-LVAD severe right ventricular failure as defined by INTERMACS criteria within previous 3 months of enrollment
6. History of pump-related infection treated within previous 3 months of enrollment or those on chronic antibiotics suppressive therapy for pump related infection
7. History of post-LVAD intra-cardiac or arterial thrombus or thromboembolic event within previous 3 months of enrollment
8. International Normalized Ratio (INR) \<2 within previous 30-days from the date of enrollment
9. Aspirin dose \<325 mg/day
10. Lactate Dehydrogenase (LDH) levels ≥ 3 times the upper normal limit in previous 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04199793
Study Brief:
Protocol Section:
NCT04199793