Early Feasibility Study of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System (TIARA-I)
		
	
		
			
				| Sponsor: | Neovasc Inc. | 
			
			
				| Enrolling: | Male and Female Patients | 
						
			
			
                            
                    | IRB Number: | AAAO5703 | 
            
			 
				
					| U.S. Govt. ID: | NCT02276547 | 
					
			
				| Contact: | Martin Leon: 212-342-3617 / ml2398@columbia.edu | 
		
	
		The purpose of this study is to  find out if the mitral valve can be safely replaced using a procedure that issimpler than the open-heart procedure being used today and may be safer for patients who are at ahigher risk from conventional open-heart surgery. The device being studied would be implanted without the need for an open-heart procedure and without the need for a heart and lung machine. This is thefirst research study for this device that will be carried out in a small number of subjects. This study is being done to learn initial information about the basic safety and function of this device.
	
			This study is closed
	
	   	
		Investigator
		
		Martin Leon, MD
		
					   
	
		
		
		
			
				
					| Are you at high surgical risk for open mitral valve surgery? | Yes | No |