Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
| Status: | Recruiting | 
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology | 
| Therapuetic Areas: | Cardiology / Vascular Diseases | 
| Healthy: | No | 
| Age Range: | 65 - Any | 
| Updated: | 3/17/2019 | 
| Start Date: | July 12, 2017 | 
| End Date: | December 2031 | 
| Contact: | Elizabeth Lau, PhD | 
| Email: | Elizabeth_Lau@edwards.com | 
| Phone: | 949-250-3592 | 
This clinical trial is a prospective, randomized, controlled, multi-center study. Patients
will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with
the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or
not they are able to perform a treadmill stress test. Patients who have a positive stress
test will be followed in a registry to collect data on subsequent treatment and mortality, as
applicable.
			will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with
the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or
not they are able to perform a treadmill stress test. Patients who have a positive stress
test will be followed in a registry to collect data on subsequent treatment and mortality, as
applicable.
Inclusion Criteria:
1. Severe aortic stenosis
2. Patient is asymptomatic
3. The study patient has been informed of the nature of the study, agrees to its
provisions and has provided written informed consent as approved by the institutional
review board of the respective clinical site.
Exclusion Criteria:
1. Patient is symptomatic.
2. Ilio-femoral vessel characteristics that would preclude safe placement of the
introducer sheath.
3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
4. Aortic valve is a unicuspid, bicuspid, or is non-calcified.
5. Severe aortic regurgitation (>3+).
6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
We found this trial at
    65
    sites
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									7000 Fannin St
Houston, Texas 77030
	
			Houston, Texas 77030
(713) 500-4472
							 
					
		University of Texas Health Science Center at Houston The University of Texas Health Science Center...  
  
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		Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...  
  
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									1211 Medical Center Dr
Nashville, Tennessee 37232
	
			Nashville, Tennessee 37232
(615) 322-5000 
							 
					
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									2500 Rocky Mountain Avenue
Loveland, Colorado 80538
	
			
					Loveland, Colorado 80538
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									100 Madison Avenue
Morristown, New Jersey 07960
	
			
					Morristown, New Jersey 07960
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		Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...  
  
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