MedTrace Logo

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

NCT01314313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2032

Last updated 2024-03-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Symptomatic Severe Aortic Stenosis

Interventions

DEVICE

TAVR Implantation with SAPIEN XT

Operable Group with SAPIEN XT

DEVICE

SAVR Implantation

Control Group

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Martin B Leon, MD · Columbia University

  • Craig Smith, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2016-01-31
Completion
2024-01-17
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01314313 on ClinicalTrials.gov