NHLBI DIR LAMPOON Study
About
Protocol Description
Intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction during transcatheter mitral valve implantation: LAMPOON is a new catheter technique to split the AML and prevent iatrogenic left ventricular outflow tract obstruction immediately before transcatheter mitral valve replacement (TMVR). It mimics surgical chord-sparing AML resection. It has been used successfully in a small number of patients. Enrollment has closed.
Eligibility Criteria
Inclusion Criteria
- Undergoing TMVR for valve-in-ring, valve-in-band or valve-in MAC
- Adults age ≥21 years
- Severe symptomatic native mitral valve failure after mitral annuloplasty repair or related to mitral annular calcification
- TMVR is felt indicated by the multi-disciplinary 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 200mm2)) 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 corelab assessment of the base-line CT and echocardiogram
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 Edwards SAPIEN 3 skirt, after LAMPOON, less than 150mm2
- 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
Primary Investigator
Jason Foerst, M.D.
Medical director of the Structural Heart and Valve Center at Carilion Clinic and an assistant professor of Medicine at the Virginia Tech Carilion School of Medicine.
Contact Information
Christina Bryant, R.N., R.C.I.S.
Clinical Research Nurse Coordinator