NCT01314313

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,032 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Symptomatic Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	TAVR Implantation with SAPIEN XT	Operable Group with SAPIEN XT
DEVICE	SAVR Implantation	Control Group

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-01-01
• Completion: 2024-01-17
• First posted: 2011-03-14
• Last updated: 2024-03-07
• Results posted: 2018-08-14

Locations

57 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study