We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03015194
Recruitment Status : Enrolling by invitation
First Posted : January 9, 2017
Last Update Posted : December 28, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


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

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Technical success, acceptable [ Time Frame: 30 d ]
  2. Technical success, optimal [ Time Frame: 30 d ]

Secondary Outcome Measures :
  1. MVARC 30-day device success [ Time Frame: 30 days ]
  2. LVOT obstruction [ Time Frame: 0d, predischarge, 30d, 12 mo ]
  3. MVARC 30-day procedure success [ Time Frame: 30 days ]
  4. MVARC 1-year patient success [ Time Frame: 1 year ]
  5. Mortality, all cause [ Time Frame: Predischarge, 30d, annually x 5 yr ]
  6. Stroke [ Time Frame: Predischarge, 30d ]
  7. Miocardial infarction [ Time Frame: Predischarge ]
  8. Access complications [ Time Frame: Predischarge ]
  9. MVARC bleeding [ Time Frame: Predischarge, 30d ]
  10. AKIN kidney injury [ Time Frame: Predischarge, 30d ]
  11. Arrhythmia and conduction disturbances [ Time Frame: Predischarge ]
  12. Infection [ Time Frame: Predischarge, 30d, 1y ]
  13. Hemolytic anemia [ Time Frame: Predischarge, 30d, 1y ]
  14. Device technical failure [ Time Frame: Predischarge, 30d ]
  15. Aortic valve regurgitation changes [ Time Frame: Predischarge, 30d, 1y ]
  16. Device thrombosis [ Time Frame: Predischarge, 30d, annually x 5 yr ]
  17. Neo LVOT area [ Time Frame: 30d ]
  18. Outcomes in elderly [ Time Frame: Predischarge, 30d, annually x 5 yr ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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


  • 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
Contacts and Locations

Information from the National Library of Medicine

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
Emory University
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
Carilion Medical Center
Roanoke, Virginia, United States, 24014
United States, Washington
University of Washington Division of Cardiology
Seattle, Washington, United States, 98195
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03015194     History of Changes
Other Study ID Numbers: 999917032
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 20, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
LVOT (left ventricular outflow tract, obstruction)
Transcatheter Mitral Valve Implantation
Transcatheter Heart Valve
Mitral Valve Regurgitation
Mitral Valve Stenosis

Additional relevant MeSH terms:
Wounds and Injuries