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RESPOND EDGE Post Market Study

NCT04009720 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-07-15

No results posted yet for this study

Summary

The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Lotus Edge Device

The LOTUS Edge Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] \<1.0 cm2 or AVA index \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Nicolas Dumonteil, MD · Clinique Pasteur

  • Rajesh K Kharbanda, MD, PhD · Oxford Heart Centre, John Radcliffe Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2020-12-09
Completion
2021-06-02
FDA Device
Yes

Countries

  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Sweden
  • United Kingdom

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 NCT04009720 on ClinicalTrials.gov