None listed
Conditions
Brief summary
The primary objective of the MitraClip System ANZ Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.
Interventions
The MitraClip System consists of a delivery catheter and an implantable Clip. The Clip is made of metal and is covered with polyester fabric. The Clip is attached to the end of a delivery catheter, which is a thin flexible tube that is used to insert and position the Clip on the mitral valve. The delivery catheter guides the Clip into place so that it can be attached to the leaflets of the mitral valve. Once the Clip is in place on the mitral valve, the delivery catheter is removed. The proce
The MitraClip System consists of a delivery catheter and an implantable Clip. The Clip is made of metal and is covered with polyester fabric. The Clip is attached to the end of a delivery catheter, which is a thin flexible tube that is used to insert and position the Clip on the mitral valve. The delivery catheter guides the Clip into place so that it can be attached to the leaflets of the mitral valve. Once the Clip is in place on the mitral valve, the delivery catheter is removed. The procedure to place the Clip will take around 3 to 4 hours and will be done under general anesthesia in the hospital. The procedure will be performed in the cardiac catheterization laboratory. This type of catheterization procedure usually requires an overnight stay in the hospital and around 24 hours to recover. The MitraClip procedure is performed using TEE and x-rays (called fluoroscopy). Participants may be required to limit physical activity for 30 days or longer after the procedure as instructed by the Trial doctor. Participants will undergo the MitraClip procedure after their doctor has carefully evaluated their MR using ultrasound and if necessary, angiography. To introduce the MitraClip System, the doctor will insert the delivery catheter into the femoral vein in the groin. The delivery catheter will then be advanced along the vein until it enters the heart. A transseptal approach is used to gain access to the mitral valve. This is done by crossing from the right to left side (i.e., the name transseptal means to cross the septum) of the heart through a small opening. This small opening is present in about 1 out of 5 people and in others a commercially available catheter is used to create a small opening by puncturing the septum. In general, this opening will seal up on its own after the procedure. The delivery catheter will then be advanced through the small opening. The doctor will position the Clip, which is at the end of the delivery catheter, to a location in the middle of the mitral valve leaflets. The Clip has two arms that are then opened to grasp the bottom of the two valve leaflets. Inside each Clip arm is a gripper. Once the arms have grasped the bottom of the leaflets, the grippers are then lowered onto the top of the leaflets, toward the arms. This causes each leaflet to be sandwiched between the arms and the grippers of the Clip. The Clip will be closed to pull the two leaflets together and locked in place. This secures the leaflets into the Clip and holds the two leaflets of the valve together at the point of the Clip. Finally, the Clip is separated from the delivery catheter. The valve will now open with two openings instead of one. At the end of the procedure, the delivery catheter will be removed and the Clip will be left in the body to help the mitral valve leaflets close sufficiently. It is possible that two Clips may be required to sufficiently reduce the mitral regurgitation. In order to place another Clip, if needed, the first delivery catheter will be removed and a new delivery catheter with the other Clip will be passed into the left side of the heart by the same approach as described above. The other Clip will then be placed adjacent to the first Clip in the same manner as previously described. It is also possible that if participants only receive one Clip during the initial procedure, a second Clip may be placed at a later date if required. Participants will be observed for 2 years as part of this clinical trial.
Sponsors
Evalve, Inc. A subsidiary of Abbott Vascular Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older. 2. Significant, chronic MR (greater than or equal to 3+) by echocardiography. 3. In the judgment of the Investigator, transseptal catheterization and femoral vein access are feasible. 4. In the judgment of the Investigator, placement of the MitraClip device on the mitral leaflets is feasible. 5. Mitral valve orifice area greater than or equal to 4.0 cm2. 6. The patient or the patient’s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the institution’s Human Research Ethics Committee (HREC) of the respective clinical site. 7. The patient agrees to return for all required post-procedure follow-up visits.
Exclusion criteria
1. Have need for emergency surgery for any reason or need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic or tricuspid disease. 2. Have undergone prior mitral valve repair surgery or have any currently implanted mechanical prosthetic valve or currently implanted ventricular assist device (VAD). 3. Have active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e., noncompliant, perforated). 4. Transesophageal echocardiography (TEE) is contraindicated. 5. Has a known hypersensitivity or contraindication to trial or procedure medications which cannot be adequately managed medically. 6. Currently participating in an investigational drug trial or another device trial that has not yet completed the primary endpoint or that otherwise clinically interferes with the MitraClip System ANZ Clinical Trial data collection. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.) 7. Pregnant or planning pregnancy within next 12 months.
Outcome results
None listed