PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
- Conditions
- Symptomatic Severe Aortic Stenosis
- Registration Number
- NCT01314313
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
- Detailed Description
The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.
To assure that patients with an STS score ≥ 4% have been selected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2032
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method All-cause Death or Disabling Stroke to Two Years 2 Years All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
- Secondary Outcome Measures
Name Time Method Adjusted Days Alive and Out of Hospital (DAOH) to Two Years 2 years The number of days the patients are alive and out of the hospital.
6MWT Change From Baseline Baseline and 2 years Six Minute Walk Test change from baseline to 2 years
Effective Orifice Area (EOA) 2 years Total Aortic Regurgitation (AR) at 2 Years 2 years Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
NYHA Classification at 2 Years 2 years New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
Trial Locations
- Locations (57)
Arkansas Heart Hospital/Clinic
🇺🇸Little Rock, Arkansas, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Scroll for more (47 remaining)Arkansas Heart Hospital/Clinic🇺🇸Little Rock, Arkansas, United States