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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

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ClinicalTrials.gov Identifier: NCT03015194
Recruitment Status : Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date January 28, 2019
Study Start Date  ICMJE January 6, 2017
Estimated Primary Completion Date December 29, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • Technical success, acceptable [ Time Frame: 30 d ]
  • Technical success, optimal [ Time Frame: 30 d ]
Change History Complete list of historical versions of study NCT03015194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Official Title  ICMJE NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Brief Summary

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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Failure
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
Publications * Khan JM, Babaliaros VC, Greenbaum AB, Foerst JR, Yazdani S, McCabe JM, Paone G, Eng MH, Leshnower BG, Gleason PT, Chen MY, Wang DD, Tian X, Stine AM, Rogers T, Lederman RJ. Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2019 May 28;73(20):2521-2534. doi: 10.1016/j.jacc.2019.02.076. Erratum in: J Am Coll Cardiol. 2019 Jul 30;74(4):595.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
60
Estimated Study Completion Date  ICMJE December 29, 2023
Estimated Primary Completion Date December 29, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015194
Other Study ID Numbers  ICMJE 999917032
17-H-N032
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date November 27, 2018

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