We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03015194
First Posted: January 9, 2017
Last Update Posted: October 27, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
January 6, 2017
January 9, 2017
October 27, 2017
January 6, 2017
December 31, 2023   (Final data collection date for primary outcome measure)
  • Technical success, acceptable [ Time Frame: 30 d ]
  • Technical success, optimal [ Time Frame: 30 d ]
Same as current
Complete list of historical versions of study NCT03015194 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation

Background:

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.

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, 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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mitral Valve Failure
  • 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.
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.
Interventions:
  • Device: Edwards SAPIEN 3 transcatheter heart valve
  • Device: ASHI INTECC Astato XS 20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
December 31, 2023
December 31, 2023   (Final data collection date for primary outcome measure)
  • 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
Sexes Eligible for Study: All
21 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03015194
999917032
17-H-N032
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
October 20, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP