NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
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|ClinicalTrials.gov Identifier: NCT03015194|
Recruitment Status : Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : October 15, 2018
Transcatheter mitral valve replacement (TMVR) is recommended for some people with 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.
To test the safety and effectiveness of the LAMPOON technique in TMVR.
Adults ages 21 and over who are recommended to have TMVR with LAMPOON
Participants will be screened with medical history and exam and by review of medical records.
Participants will have blood tests, a scan, and a heart test before the procedure.
Participants will have TMVR with LAMPOON. They will have anesthesia. Doctors will use a wire to split the diseased mitral valve and move it out of the way. They will replace a heart valve.
Participants will stay in the hospital for about 1 month.
They will repeat the previous tests before leaving the hospital, 1 month 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.
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Failure||Device: Edwards SAPIEN 3 transcatheter heart valve Device: ASHI INTECC Astato XS 20||Phase 2|
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 tear 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation|
|Study Start Date :||January 6, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 29, 2023|
Experimental: Arm 1
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 TEE or intracardiac echocardiography.
Device: Edwards SAPIEN 3 transcatheter heart valve
Used to relieve aortic stenosis in patients with symptomatic heart disease
Device: ASHI INTECC Astato XS 20
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.
- Technical success, acceptable [ Time Frame: 30 d ]The primary endpoint is Technical success ACCEPTABLE (measured at exit from the catheterization la-boratory)19. All of the following must be present:- 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) consen- sus endpoint19, specific forLAMPOON procedure.
- Technical success, optimal [ Time Frame: 30 d ]Based on feedback from the FDA, the co-primary endpoint is Technical Success OPTIMAL (measured at exit from the catheterization laboratory).This differs from O only in the magnitude of the peak LVOT gradient.All of the following must be present:- Successful LAMPOON traversal and laceration; and- Peak LVOT gradient less than 3O 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.
- MVARC 30-day device success [ Time Frame: 30 days ]
- LVOT obstruction [ Time Frame: 0d, predischarge, 30d, 12 mo ]
- MVARC 30-day procedure success [ Time Frame: 30 days ]
- MVARC 1-year patient success [ Time Frame: 1 year ]
- Mortality, all cause [ Time Frame: Predischarge, 30d, annually x 5 yr ]
- Stroke [ Time Frame: Predischarge, 30d ]
- Miocardial infarction [ Time Frame: Predischarge ]
- Access complications [ Time Frame: Predischarge ]
- MVARC bleeding [ Time Frame: Predischarge, 30d ]
- AKIN kidney injury [ Time Frame: Predischarge, 30d ]
- Arrhythmia and conduction disturbances [ Time Frame: Predischarge ]
- Infection [ Time Frame: Predischarge, 30d, 1y ]
- Hemolytic anemia [ Time Frame: Predischarge, 30d, 1y ]
- Device technical failure [ Time Frame: Predischarge, 30d ]
- Aortic valve regurgitation changes [ Time Frame: Predischarge, 30d, 1y ]
- Device thrombosis [ Time Frame: Predischarge, 30d, annually x 5 yr ]
- Neo LVOT area [ Time Frame: 30d ]
- Outcomes in elderly [ Time Frame: Predischarge, 30d, annually x 5 yr ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015194
|United States, District of Columbia|
|Medstar Washington Hospital Center, Cardiovascular Research Program|
|Washington, District of Columbia, United States, 20010|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322-1102|
|United States, Illinois|
|St. John's Hospital (enrollment), Springfield, IL; Prairie Education|
|Springfield, Illinois, United States, 62701|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Virginia|
|INOVA Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Carilion Medical Center|
|Roanoke, Virginia, United States, 24014|
|United States, Washington|
|University of Washington Division of Cardiology|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Robert J Lederman, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|