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

NCT ID: NCT03015194

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2023-04-13

Brief 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.

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.

Conditions

Mitral Valve Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Edwards SAPIEN 3 transcatheter heart valve

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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 (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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Lederman, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

Medstar Washington Hospital Center, Cardiovascular Research Program

Washington D.C., District of Columbia, 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

Countries

United States

References

Khan JM, Babaliaros VC, Greenbaum AB, McCabe JM, Rogers T, Eng MH, Foerst JR, Yazdani S, Paone G, Gleason PT, Halaby RN, Bruce CG, Tian X, Stine AM, Lederman RJ. 5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2157-2167. doi: 10.1016/j.jcin.2024.05.041. Epub 2024 Sep 4.

Reference Type: DERIVED

PMID: 39243268 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31118146 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-H-N032

Identifier Type: -

Identifier Source: secondary_id

999917032

Identifier Type: -

Identifier Source: org_study_id