NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
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
