This clinical trial is for men and women who are diagnosed with severe aortic stenosis and are at intermediate-risk for traditional open-heart surgery for aortic valve replacement.
The purpose of the study is to assess the safety and effectiveness of the SAPIEN XT and SAPIEN 3 transcatheter heart valves. Unlike traditional replacement aortic valves, they are implanted with a catheter procedure to eliminate the need for surgery. These devices are approved by FDA for patients who are at high-risk for traditional open-heart surgery.
Study subjects will be followed up for 5 years after placement of the stent.
Men and women age 18 and older with senile degenerative aortic valve stenosis and heart failure assessed at NYHA Functional Class II or greater. Additional assessments will determine surgical risk.
Detailed eligibility requirements will be reviewed when you contact the study team.
Dolores Reynolds, R.N., phone 212-746-4617, email firstname.lastname@example.org.
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves. ClinicalTrials.gov Identifier NCT01314313