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

NCT02184442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2018-09-25

Study results available
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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.

Conditions

  • Severe
  • Symptomatic
  • Calcific Aortic Stenosis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Martin B Leon, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-09
Primary Completion
2013-05-01
Completion
2017-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02184442 on ClinicalTrials.gov