Clinical Trials
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Principal Investigator:
Susheel Kumar Kodali, MDThis Early Feasibility Study (EFS) is looking at the investigative device called the Half Moon TMVrSystem to see if it is safe and effective in treating patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery. The system is designed so that a catheter can gain access to the heart by way of a large artery in the leg or by a small surgical passage through the walls between the right and left chamber of the heart. The implant then anchors on the leaflets of the valve in a certain manner. The Transcatheter Mitral Valve Replacement system... -
Principal Investigator:
Michael B Collins, MDThis is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to what is currently used for patients with reduced left-sided heart function. Participants will be assigned by the flip of a coin to receive the Impella device, or assigned to receive standard of care treatment. Participants will have a... -
Principal Investigator:
Susheel Kumar Kodali, MDThis is a prospective, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. The goal of this study is to evaluate the safety and performance of the Evoque system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of... -
Principal Investigator:
Susheel Kumar Kodali, MDThis is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. The goal of this study is to gain early clinical insight into how the Intrepid transcatheter tricuspid valve replacement (TTVR) system device performs. There is a need for alternative and less invasive treatment options to treat this...