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:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT01481012
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent, release of medical information, and HIPAA forms;
2. Age greater than or equal to 18 years;
3. Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test;
4. Admitted to the clinical center at the time of enrollment;
5. Approved and scheduled to undergo one of the following within 24 hours of enrollment:
* Orthotopic heart transplantation
* CABG and/or valve surgery on CPB; these patients must have an LV ejection fraction of ≤35%
* Implantation of a pulsatile LVAD (e.g.Thoratec HeartMate® I LVAD) for destination therapy or bridge to transplantation
* Implantation of a continuous flow LVAD (e.g. HeartMate® II, DeBakey VAD® or VentrAssist® LVAS) for destination therapy or bridge to transplantation
Exclusion Criteria:
1. History of a platelet disorder;
2. History of a known, or an inherited, or an acquired coagulation disorder in the study subject;
3. Stroke within 30 days prior to enrollment;
4. Allergy to heparin or protamine;
5. Participation in a clinical investigational intervention trial, with the exception of an investigational VAD trial, at the time of enrollment;
6. Received investigational intervention within 30 days of enrollment, with the exception of an investigational VAD trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01481012
Study Brief:
Protocol Section:
NCT01481012