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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT07081035
Eligibility Criteria:
Inclusion Criteria:
* Patients who meet all of the following criteria will be eligible for randomization:
Adults aged ≥19 years who have successfully undergone implantation of a HeartMate 3 LVAD.
Patients who are at least 30 days post-implantation of HeartMate 3 LVAD.
Patients who have maintained stable anticoagulation therapy with standard INR (2.0-3.0) for at least 30 days post-LVAD implantation.
Patients or their legal representatives who provide documented informed consent and agree to the study protocol and follow-up schedule.
Exclusion Criteria:
* Patients who meet any of the following criteria will be excluded:
Patients implanted with any mechanical assist device other than HeartMate 3 LVAD (e.g., other LVAD models, RVAD, BiVAD).
Patients with a clinically significant stroke or transient ischemic attack (TIA) within the past 6 months.
Patients with a history of hemorrhagic stroke.
Patients who experienced major bleeding events within the past 6 months (based on INTERMACS major bleeding criteria).
Patients with uncontrolled severe hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg).
Patients requiring active treatment or surgical intervention for acute LVAD-related thrombosis or hemodynamic instability, or patients who underwent LVAD-related reoperation within the past 30 days.
Patients with severe renal dysfunction (estimated Glomerular Filtration Rate \<15 mL/min) or patients undergoing dialysis.
Patients with severe liver dysfunction causing coagulation abnormalities or those classified as Child-Pugh class B or C.
Patients with active bleeding or ongoing hemorrhagic conditions.
Patients with a high bleeding risk due to:
Gastrointestinal bleeding or ulcers within the past 6 months.
Surgery involving the brain, spine, or eyes within the past 6 months.
Major central nervous system, ophthalmologic, or major open surgical procedures within the past 6 months.
Presence or suspicion of esophageal varices.
Arteriovenous malformation or vascular aneurysm.
Patients who have received thrombolytic therapy for bleeding or thromboembolism within the past 30 days.
Patients receiving long-term concurrent treatment with other anticoagulants (low molecular weight heparin, NOAC, Fondaparinux, etc.). However, temporary administration for warfarin bridging or heparin use for central venous or arterial catheter maintenance is permitted.
Patients with persistent anemia (hemoglobin \<8 g/dL) or thrombocytopenia (platelet count \<50,000/µL) within the past 6 months.
Patients currently experiencing infective endocarditis.
Patients with a history of severe allergy or hypersensitivity to warfarin or other anticoagulants used in this study.
Pregnant or lactating women, or women planning pregnancy during the study period.
Patients with severe terminal illness with a life expectancy of less than 12 months.
Patients with alcohol dependence or severe psychiatric conditions hindering study participation.
Patients unwilling or unable to adhere to the procedures or evaluations required by the study protocol.
Patients currently participating in another randomized drug or medical device clinical trial who have not yet completed the primary endpoint assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07081035
Study Brief:
Protocol Section:
NCT07081035