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

July 24, 2023 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Background:

Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve 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, an ECG, a heart CT scan, and an echocardiogram before the procedure.

Participants will have TMVR with LAMPOON. They will have anesthesia or moderate sedation for the procedure. Doctors will use a wire to split the diseased mitral valve and move it out of the way before inserting the artificial mitral valve.

Participants will recover in an inpatient recovery unit.

They will repeat the previous tests before leaving the hospital, 1 month later, 6 months 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 split 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

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Washington Hospital Center, Cardiovascular Research Program
    • Georgia
      • Atlanta, Georgia, United States, 30322-1102
        • Emory University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Roanoke, Virginia, United States, 24014
        • Carilion Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Division of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
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 transesophageal echocardiogram (TEE) or intracardiac echocardiography.
Device: Edwards SAPIEN 3 transcatheter heart valve

Used to relieve aortic stenosis in patients with symptomatic heart disease

In this study it is not used for aortic stenosis-----the device is used in the mitral valve position.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Time Frame: Exit from the Cardiac Catheterization Laboratory

Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria:

  • 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) consensus endpoint, specific for LAMPOON procedure.
Exit from the Cardiac Catheterization Laboratory
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Time Frame: Exit from the Cardiac Catheterization Laboratory

Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria:

  • Successful LAMPOON traversal and laceration; and
  • Peak LVOT gradient < 30 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) consensus endpoint, specific for LAMPOON procedure.
Exit from the Cardiac Catheterization Laboratory

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Robert J Lederman, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

April 13, 2023

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimated)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999917032
  • 17-H-N032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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