PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
- Conditions
- Symptomatic Severe Aortic Stenosis
- Registration Number
- NCT03222128
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
- Detailed Description
This study design consists of PIIS3i cohort.
The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access.
To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1074
Not provided
-
Heart team assessment of inoperability (including examining cardiac surgeon).
-
Complex coronary artery disease
- Unprotected left main coronary artery
- Syntax score > 32 (in the absence of prior revascularization)
-
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.
-
Need for emergency surgery for any reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate 1 year
- Secondary Outcome Measures
Name Time Method Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days 30 Days
Trial Locations
- Locations (51)
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mercy General Hospital
🇺🇸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
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Scroll for more (41 remaining)Scripps Green Hospital🇺🇸La Jolla, California, United States