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

Mitral Valve Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015194
• Other study ID #: 999917032
• Secondary ID: 17-H-N032
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: April 13, 2023

Study information

• Verified date: March 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 13, 2023
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lacerations
• Mitral Valve Failure
• Ventricular Outflow Obstruction, Left

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Henry Ford Hospital	Detroit	Michigan
United States	INOVA Fairfax Hospital	Falls Church	Virginia
United States	Carilion Medical Center	Roanoke	Virginia
United States	University of Washington Division of Cardiology	Seattle	Washington
United States	Medstar Washington Hospital Center, Cardiovascular Research Program	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure	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
Primary	Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure	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