NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ve… (NCT03015194) | Clinical Trial Compass
CompletedNot Applicable
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
United States32 participantsStarted 2017-06-20
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
Timeframe: Exit from the Cardiac Catheterization Laboratory
2
Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
Timeframe: Exit from the Cardiac Catheterization Laboratory
Trial details
NCT IDNCT03015194
SponsorNational Heart, Lung, and Blood Institute (NHLBI)