search
Back to results

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

Primary Purpose

Mitral Valve Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Edwards SAPIEN 3 transcatheter heart valve
ASHI INTECC Astato XS 20
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Failure focused on measuring LVOT (left ventricular outflow tract, obstruction), Transcatheter Mitral Valve Implantation, Transcatheter Heart Valve, Mitral Valve Regurgitation, Mitral Valve Stenosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medstar Washington Hospital Center, Cardiovascular Research Program
  • Emory University
  • Henry Ford Hospital
  • INOVA Fairfax Hospital
  • Carilion Medical Center
  • University of Washington Division of Cardiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2017
Last Updated
July 24, 2023
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03015194
Brief Title
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
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Failure
Keywords
LVOT (left ventricular outflow tract, obstruction), Transcatheter Mitral Valve Implantation, Transcatheter Heart Valve, Mitral Valve Regurgitation, Mitral Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Edwards SAPIEN 3 transcatheter heart valve
Intervention Description
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
Intervention Name(s)
ASHI INTECC Astato XS 20
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Description
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.
Time Frame
Exit from the Cardiac Catheterization Laboratory
Title
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Description
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.
Time Frame
Exit from the Cardiac Catheterization Laboratory

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Lederman, M.D.
Organizational Affiliation
National Heart, Lung, and Blood Institute (NHLBI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Washington Hospital Center, Cardiovascular Research Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1102
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Washington Division of Cardiology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31118146
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs