Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation APOLLO Trial

Brief description of study

The purpose of this study is to see how safe and effective an investigational device called Intrepid TMVR system is for mitral regurgitation. TMVR stands for transcatheter mitral valve replacement. Investigational means that it is not an approved treatment for mitral regurgitation in United States and that the benefits and risks of the device for treatment of mitral regurgitation are not fully known. Mitral valve regurgitation (MR) occurs when the two leaflets of your mitral valve do not close correctly and blood leaks backward with each heart-beat. Because some blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward to give to the rest of your body. If this is not treated, there is a risk that the heart may begin to fail, and patients may have symptoms such as shortness of breath or tiredness. One treatment for mitral regurgitation is open-heart surgery to replace a leaky mitral valve with an artificial, man-made heart valve. The TMVR system has been successfully implanted in pigs, which have a heart similar to humans. The first human implants have happened in studies similar to this. The first human experience suggests the Intrepid TMVR system may work as intended.

Clinical Study Identifier: s19-00755 Identifier: NCT03242642
Principal Investigator: Mathew R. Williams.

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