NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点