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

NCT03015194 | Completed Results FDA Device

• 2 other identifiers: 99991703217-H-N032
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

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.

Conditions

Mitral Valve Failure

Keywords

LVOT (left ventricular outflow tract, obstruction); Transcatheter Mitral Valve Implantation; Transcatheter Heart Valve; Mitral Valve Regurgitation; Mitral Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option

EXPERIMENTAL

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; Device: ASHI INTECC Astato XS 20

Interventions

Edwards SAPIEN 3 transcatheter heart valve 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.

Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option

ASHI INTECC Astato XS 20 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.

Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (6)

Medstar Washington Hospital Center, Cardiovascular Research Program

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322-1102, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

University of Washington Division of Cardiology

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 39243268 DERIVED

• 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.

  PMID: 31118146 DERIVED

MeSH Terms

Conditions

Bites and Stings; Mitral Valve Insufficiency; Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

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

ledermar@nhlbi.nih.gov

301.402.6769

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 9, 2017
• Study Start: June 20, 2017
• Primary Completion: July 26, 2018
• Study Completion: April 13, 2023
• Last Updated: August 15, 2023
• Results First Posted: April 29, 2021

Record last verified: 2023-03

Locations

US (6)