CAUTION: The Intrepid™ Transcatheter Mitral Valve Replacement System is an investigational device. Limited by federal (United States) law to investigational use. Exclusively for clinical investigations. Not approved by FDA and not for sale in the United States.
The APOLLO Trial is studying the safety and efficacy of an investigative device called the Intrepid Transcatheter Mitral Valve Replacement System.
The Intrepid device is a heart valve that is designed to help alleviate mitral regurgitation so that blood can flow through your heart in the intended direction.
Your heart has four valves that move blood in and out of its four chambers. One of the valves is a mitral valve. When a mitral valve is functioning normally, it regulates blood flow from the upper chamber (left atrium) of your heart to the lower chamber of your heart (left ventricle). However, when the mitral valve is diseased, it may not close tightly and blood can leak back into the left atrium, where it came from. This is known as a "leaky valve" or mitral regurgitation (MR). The APOLLO Trial is investigating a therapy option for mitral regurgitation.
Depending on the severity of MR, current treatment options may include:
Today, mitral valve replacement requires surgery. Medtronic is conducting a clinical trial of an investigational, potentially less-invasive catheter-based alternative:transcatheter mitral valve replacement (TMVR).
Chambers of the Heart and Mitral Valve
This is a procedure that will require you to be in the hospital. Your doctor will begin by giving you some anesthesia. Then your doctor will select one of two ways to place the Intrepid device through a tube (also called a catheter) into your heart. One way is through an incision in your groin through your femoral vein. The other way is through an incision made in a space between your ribs. Either way, they will use ultrasound and X-ray images to guide the catheter to your mitral valve, insert the Intrepid valve there, and remove the catheter. The Intrepid valve will stay in your heart and replaces your diseased mitral valve.
After your heart procedure, plan to stay in the hospital for a short time. Once your doctor releases you, expect several follow-up appointments each year. Expect to have this type of appointment for at least five years and up to ten, so your doctor can continue to monitor how you feel.
The risks of joining this trial are similar to the risks with other heart surgeries (these other surgeries have names like standard mitral valve surgery, repair, and replacement).
These risks could include, but are not limited to:
Please view the important safety information. For a full list of risks, speak with your doctor.
All clinical trials have guidelines about who can participate, which are called inclusion/exclusion criteria. Read through some of the eligibility criteria and view more resources.