What are the intended benefits of receiving the Meridian® Valve?
Patients may experience an improvement in symptoms and quality of life.
What is the Meridian® Valve made of?
The valve is made from treated animal tissue that is supported on a wire frame so it can be placed in the heart.
How long does the procedure take to implant the valve?
A transcatheter valve replacement procedure may take 2-4 hours.
What happens to the old valve?
The diseased valve remains in the heart. During the procedure, the diseased valve is pushed aside, which allows the new transcatheter valve to be secured in position.
How long will the valve last?
The Meridian® Valve was tested in a laboratory setting to meet standards for valve durability. There is no patient information available yet on the long-term performance of the valve. The clinical trial is designed to follow patients over many years to understand more about valve durability.
Who manufactures the valve?
HLT, Inc. a medical device company based in Minnesota, USA, manufactures the Meridian® Valve .
What is a clinical trial?
A clinical trial is a research study conducted to answer specific health care related questions. The trial will collect information on the safety and performance of the new Meridian® Valve .
Patients may volunteer to participate in a clinical trial after learning about the study and any potential risks. Every patient enrolled in the study is required to provide their informed consent prior to participation.
Patients in clinical trials can be more involved in their health care and have access to new treatments before they are widely available. Data from a clinical trial can provide new medical information that helps doctors treat patients with similar health problems.
To find out more about this clinical trial or to find out if you qualify, go to www.clinicaltrials.gov