Allegheny Health Network
Find a
Doctor
Request An Appointment Login to
MyChart
Patient
Center
News Classes &
Events
Contact
Us
Call 412.Doctors

Active Clinical Trials

The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

Active NCT:
02675114
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Edwards Lifesciences
Contact: 

For more information, please contact Brooke Thomas at 412-359-6908 or Brooke.Thomas@ahn.org.

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement (2015-08)

Purpose: 

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Ages Eligible for Study:  19 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

No age restriction.

Severe, calcific aortic stenosis.

Heart team agrees the patient has a risk of operative mortality and has an STS <4.

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 (IRB)/Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.

Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.

Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.

Severe aortic regurgitation (>3+).

Severe mitral regurgitation (>3+).