CLINICAL TRIAL AGREEMENT FOR THE TRANSCATHETER MITRAL VALVE REPLACEMENT WITH THE MEDTRONIC INTREPID TMVR SYSTEM IN PATIENTS WITH SEVERE SYMPTOMATIC MITRAL REGURGITATION APOLLO TRIAL

Brief description of study

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. This research is a Pivotal Study of mitral valve replacement using a new, investigational device. This 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. It also means you will be among the first people in the world to have this valve implanted. This research is being sponsored by Medtronic.AL


Clinical Study Identifier: s18-01654
ClinicalTrials.gov Identifier: NCT03242642
Principal Investigator: Richard K Schwartz.
Other Investigators: Aasha S Gopal, Anthony T Gambino, Shant J Manoushagian, Giorgio A Medranda, Sunil Abrol, Kevin P Marzo, Mohammed N Imam, Scott L Schubach, Richard B Jacaruso, Beevash Ray, George Gubernikoff, Khaled F Salhab.


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