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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT03015194
Eligibility Criteria:
INCLUSION CRITERIA:
* Adults age greater than or equal to 21 years
* Severe symptomatic native mitral valve failure after mitral annuloplasty repair or related to mitral annular calcification.
* Unacceptably high or prohibitive risk for surgical mitral valve replacement and indicated for transcatheter mitral valve replacement (TMVR) as determined by the multidisciplinary institutional heart team, including at least one cardiovascular surgeon who has examined the patient.
* High or prohibitive risk of LVOT obstruction (predicted neo-LVOT less than 200 mm2) or transcatheter heart valve dysfunction from long/redundant anterior mitral valve leaflet, as determined by the multidisciplinary institutional heart team.
* Anatomic eligibility for LAMPOON based on core lab assessment of the baseline CT and echocardiogram.
* Concordance of the study selection team
EXCLUSION CRITERIA
* Subjects unable to consent to participate, unless the subject has a legally authorized representative
* Subjects unwilling to participate or unwilling to return for study follow-up activities.
* Predicted neo-LVOT created by the Sapien-3 skirt, after LAMPOON, less than 150 mm2
* TAVR within 6 weeks
* Intended concurrent structural heart procedure, such as aortic or tricuspid valve implantation
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03015194
Study Brief:
Protocol Section:
NCT03015194