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REPRISE EDGE 29 mm EU Study

NCT02964962 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-05

No results posted yet for this study

Summary

The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical aortic valve replacement (SAVR).

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

29 mm LOTUS Edge™ Valve System

Transcatheter aortic valve replacement

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-10-30
Completion
2018-12-30

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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 NCT02964962 on ClinicalTrials.gov