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RESPOND Post Market Study

NCT02031302 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1064

Last updated 2021-11-19

Study results available
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Summary

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

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Lotus Valve System

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Nicolas Van Mieghem, MD · Erasmus Medical Center

  • Volkmar Falk, MD, PhD · German Heart Center Berlin

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-27
Primary Completion
2017-04-04
Completion
2021-05-18

Countries

  • Colombia
  • Finland
  • Germany
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT02031302 on ClinicalTrials.gov