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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT00853632
Eligibility Criteria:
Inclusion Criteria:
* The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
* The patient has signed and dated the subject informed consent form prior to surgery.
* The patient is expected to survive the surgery and be discharged.
* The patient is geographically stable and agrees to attend follow-up assessments.
* The patient is 18 years or older.
Exclusion Criteria:
* The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
* The patient presents with active endocarditis within the last 3 months.
* The patient is pregnant or lactating.
* The patient is an intravenous drug abuser.
* The patient is currently a prison inmate.
* The patient is currently participating in a study of an investigational drug or device.
* The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
* The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)\*.
* The patient was previously enrolled in the study.
* The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00853632
Study Brief:
Protocol Section:
NCT00853632