NCT02184442

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Detailed description

Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable). Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

Conditions

• Severe
• Symptomatic
• Calcific Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	TAVR Implantation with SAPIEN XT	Inoperable operable patients requiring the transcatheter aortic heart valve replacement
DEVICE	TAVR Implantation with SAPIEN	Inoperable operable patients requiring the transcatheter aortic heart valve replacement

Timeline

• Start date: 2011-03-09
• Primary completion: 2013-05-01
• Completion: 2017-05-30
• First posted: 2014-07-09
• Last updated: 2018-09-25
• Results posted: 2018-08-14

Locations

53 sites across 1 country: United States

Regulatory

• FDA-regulated device study