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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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 11, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT03015194
First received: January 6, 2017
Last updated: June 1, 2017
Last verified: May 11, 2017
  Purpose

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.


Condition Intervention Phase
Mitral Valve Failure Device: Edwards SAPIEN 3 transcatheter heart valve Device: ASHI INTECC Astato XS 20 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Primary Outcome Measures:
  • Technical success, acceptable [ Time Frame: 30 d ]
  • Technical success, optimal [ Time Frame: 30 d ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 3, 2017
Estimated Study Completion Date: December 31, 2023
Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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 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.
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03015194

Contacts
Contact: Robert J Lederman, M.D. (301) 402-6769 lederman@nih.gov

Locations
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322-1102
Contact: Vasilis Babaliaros    678-557-4514    vbabali@emory.edu   
United States, Illinois
North Shore University Health System Evanston Hospital Not yet recruiting
Evanston, Illinois, United States, 60201
St. John s Hospital Prairie Education & Research Co-operativ Not yet recruiting
Springfiled, Illinois, United States, 62701
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Adam Greenbaum, M.D.    313-926-3826    agreenb1@hfhs.org   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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
17-H-N032
Study First Received: January 6, 2017
Last Updated: June 1, 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:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on June 28, 2017