CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,822 enrolled
Drug / intervention
SAPIEN S3 valvedevice
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/NCT02687035
NCT02687035N/ACompleted
CompareCT.gov

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)

Edwards Lifesciences·interventional·Posted Feb 22, 2016·Updated Apr 8, 2021

In Brief

A clinical study evaluating SAPIEN S3 valve for Aortic Stenosis. Completed, enrolled 1,822 participants across 56 sites in 2 countries.

Detailed Summary

Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.

Study Details

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

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 22, 2016
Enrollment StartJan 1, 2015
Primary CompletionOct 1, 2017
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.4 years ago

Interventions

SAPIEN S3 valvedevice

Transcatheter aortic valve replacement