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REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System

NCT02854319 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-05-31

No results posted yet for this study

Summary

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

LOTUS Edge Valve System

Transcatheter Aortic Valve Implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Matthias Götberg, MD, PhD · Skane University Hospital

  • Sabine Bleiziffer, MD · German Heart Centre München

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-07
Primary Completion
2016-10-25
Completion
2018-03-13

Countries

  • Denmark
  • France
  • Sweden

Study Locations

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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 NCT02854319 on ClinicalTrials.gov