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

Study Overview
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Brief Summary
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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.

Detailed Description
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Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist. In as many as half of patients, TMVR can cause life-threatening blockage of the left ventricle by displacing the existing mitral valve leaflet. For these patients the only options appear to avoid TMVR or in some to cause a focused heart attack and to wait 6 weeks. The investigators have developed and tested a technique to split the existing mitral valve leaflet and enable TMVR in patients who have no other options. The procedure is called intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON). Although there are no dedicated TMVR devices commercially available, there has been short-term success with implanted transcatheter aortic valve devices in the mitral position for TMVR. The purpose of this study is to perform LAMPOON and TMVR in patients who have no good options to treat their mitral valve failure, using heart valve devices designed to implant in the aortic valve position.

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

Conditions
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Mitral Valve Failure

Intervention / Treatment
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* Device: Edwards SAPIEN 3 transcatheter heart valve
* Device: ASHI INTECC Astato XS 20


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option<br>The LAMPOON procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography. | Device: Edwards SAPIEN 3 transcatheter heart valve<br>* Used to relieve aortic stenosis in patients with symptomatic heart disease In this study it is not used for aortic stenosis-----the device is used in the mitral valve position.<br>Device: ASHI INTECC Astato XS 20<br>* The Astato 0.014 guidewire is used for transcatheter electrosurgery in two steps in this procedure. First it is used for leaflet traversal during electrification. This procedure is similar to the use of the Astato XS20 and an amputated Asahi Confienza Pro 12 in the transcaval IDE investigation recently published. Second, the midshaft is focally denuded and electrified for the leaflet traversal step.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an acceptable technical success met the following criteria: Successful LAMPOON traversal and laceration; and Peak LVOT gradient < 50 mm Hg; and Absence of procedural mortality; and Successful access, delivery, and retrieval of the LAMPOON device system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure. The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure. | Exit from the Cardiac Catheterization Laboratory | 
| Number of Participants With Optimal Technical Success of the LAMPOON Procedure | Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an acceptable technical success met the following criteria: Successful LAMPOON traversal and laceration; and Peak LVOT gradient < 30 mm Hg; and Absence of procedural mortality; and Successful access, delivery, and retrieval of the LAMPOON device system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure. The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure. | Exit from the Cardiac Catheterization Laboratory | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVOT (left ventricular outflow tract, obstruction), Transcatheter Mitral Valve Implantation, Transcatheter Heart Valve, Mitral Valve Regurgitation, Mitral Valve Stenosis