Mitral Valve Failure
Conditions
Keywords
LVOT (left ventricular outflow tract, obstruction), Transcatheter Mitral Valve Implantation, Transcatheter Heart Valve, Mitral Valve Regurgitation, Mitral Valve Stenosis
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.
Interventions
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.
DEVICEASHI INTECC Astato XS 20
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Protocol enrolled 32 participants, however 2 participants had screen failed.
Participants by arm
| Arm | Count |
|---|---|
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with 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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option |
|---|---|
| Age, Continuous | 76 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 30 |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 30 / 30 |
Outcome results
Primary
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.
Time frame: Exit from the Cardiac Catheterization Laboratory
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | Successful LAMPOON traversal and laceration | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | LVOT gradient <50 mm Hg | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | Procedure survival | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | Successful access, delivery, and retrieval of LAMPOON device system | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | Successful deployment and correct positioning of the first intended device | 27 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Acceptable Technical Success of the LAMPOON Procedure | Freedom from emergency surgery or reintervention related to the device or access procedure | 22 participants |
Primary
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.
Time frame: Exit from the Cardiac Catheterization Laboratory
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Optimal Technical Success of the LAMPOON Procedure | Successful LAMPOON traversal and laceration | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Optimal Technical Success of the LAMPOON Procedure | LVOT gradient <30 mm Hg | 29 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Optimal Technical Success of the LAMPOON Procedure | Procedure survival | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Optimal Technical Success of the LAMPOON Procedure | Successful access, delivery, and retrieval of LAMPOON device system | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Optimal Technical Success of the LAMPOON Procedure | Successful deployment and correct positioning of the first intended device | 30 participants |
| Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option | Number of Participants With Optimal Technical Success of the LAMPOON Procedure | Freedom from emergency surgery or reintervention related to the device or access procedure | 22 participants |