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The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

NCT01876420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-22

Study results available
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Summary

To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

The CoreValve™ Evolut R TAV™ system

CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Eric Vang, PhD · Director Clinical Research Structural Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-08-31
Completion
2016-10-31

Countries

  • Australia
  • New Zealand
  • United Kingdom

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 NCT01876420 on ClinicalTrials.gov