NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation

Completed · Not applicable

Conditions studied: Mitral Valve Failure

In brief

Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people. A new technique is called LAMPOON. It may have less risk of obstruction. Participants in this study will be among the first in the world to have this technique done. Objectives: To test the safety and effectiveness of the LAMPOON technique in TMVR. Eligibility: Adults ages 21 and over who are recommended to have TMVR with LAMPOON Design: Participants will be screened with medical history and exam and by review of medical records. Participants will have blood tests, an ECG, a heart CT scan, and an echocardiogram before the procedure. Participants will have TMVR with LAMPOON. They will have anesthesia or moderate sedation for the procedure. Doctors will use a wire to split the diseased mitral valve and move it out of the way before inserting the artificial mitral valve. Participants will recover in an inpatient recovery unit. They will repeat the previous tests before leaving the hospital, 1 month later, 6 months later and 1 year later. They will have yearly follow-up phone calls for about 5 years. In the event of a participant's death, researchers will ask for an autopsy and to analyze the heart. Permission for this is not required as part of the study.

Key facts

Study ID

NCT03015194

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

32

Starts

2017-06-20

Expected to finish

2023-04-13

Last updated by the study team

2023-08-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medstar Washington Hospital Center, Cardiovascular Research Program — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• INOVA Fairfax Hospital — Falls Church, Virginia, United States
• Carilion Medical Center — Roanoke, Virginia, United States
• University of Washington Division of Cardiology — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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