Partner II CAP S3i

The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [Edwards Study 2010-12]: Continued Access Program Cohort

Partner II CAP S3i [NCT01314313]

Description: The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems (transfemoral, transapical and transaortic) which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis; Device: AVR with a surgical heart valve

 

Primary Investigator: Kereiakes
Other Investigator(s): Sarembock, Ivey

Drug/Device Information
The purpose of this protocol is to provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve Model 9600TFX and delivery systems (transfemoral, transapical and transaortic)
Intended for use in patients with symptomatic, calcific, severe aortic stenosis for patients with intermediate risk for standard aortic valve replacement
Non randomized
Edwards Lifesciences LLC
Major Inclusion and Exclusion
Patients must be covered by Medicare
Intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors
Senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40 mmHg or jet velocity > 4.0 m/s
Aortic valve area (AVA) of ≤ 0.8 cm2 or indexed EOA < 0.5 cm2/m2
Aortic valve annulus area range 273mm - 680 mm2
No acute myocardial infarction ≤ 1 month (30 days)
No mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
No severe ventricular dysfunction with LVEF < 20%
No Hgb < 9 g/dL
No creatinine > 3.0 mg/dL
No active upper GI bleeding within 3 months (90 days)
Available sizes 20, 23, 26, 29 mm