Completed

NCT Number: NCT03015194

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

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.

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Key information

Conditions

Mitral Valve Failure Bites and Stings Cardiovascular Diseases Chemically-Induced Disorders Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Mitral Valve Stenosis Poisoning Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medstar Washington Hospital Center, Cardiovascular Research Program, Washington D.C., District of Columbia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2023
First posted: Jan 9, 2017
Registry last updated: Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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