Status:
TERMINATED
RESPOND EDGE Post Market Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief 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 demonstr...
Detailed Description
The RESPOND EDGE study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the comme...
Eligibility Criteria
Inclusion
- Subjects will be evaluated for eligibility by the clinical center's heart team per the local standard of practice in accordance with the Directions for Use.
Exclusion
Key Trial Info
Start Date :
October 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 2 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04009720
Start Date
October 11 2019
End Date
June 2 2021
Last Update
July 15 2021
Active Locations (13)
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1
Rigshospitalet
Copenhagen, Denmark
2
University Helsinki
Helsinki, Finland, 00290
3
Clinique Pasteur
Toulouse, France
4
Herzzentrum Universität Leipzig
Leipzig, Germany, 50937