NCT03222141

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for High Risk and Inoperable Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 583 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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, severe aortic stenosis, and are in high risk.

Detailed description

This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).

Conditions

• Symptomatic Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	TAVR Implantation of the THV Prosthesis	Patients with TAVR implantation

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-09-01
• Completion: 2020-08-01
• First posted: 2017-07-19
• Last updated: 2021-05-12
• Results posted: 2018-08-14

Locations

40 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study