CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,057 enrolled
Drug / intervention
Edwards SAPIEN Transcatheter Heart Valve +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00530894
NCT00530894N/ACompleted

THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve

Edwards Lifesciences·interventional·Posted Sep 18, 2007·Updated Sep 13, 2017

In Brief

A clinical study evaluating Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, and 1 other intervention for Critical Aortic Stenosis. Completed, enrolled 1,057 participants across 26 sites in 3 countries.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Germany, United States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2007
Enrollment StartApr 1, 2007
Primary CompletionSep 1, 2010
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.8 years ago

Interventions

Edwards SAPIEN Transcatheter Heart Valvedevice

Surgical Valve Replacementdevice

medical management and/or balloon aortic valvuloplastyother