NCT04009720 - RESPOND EDGE Post Market Study | Biotech Hunter

Enrollment

200

Participants

Timeline

Start Date

October 11, 2019

Primary Completion Date

December 9, 2020

Study Completion Date

June 2, 2021

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.

Trial Locations (13)

50937

Herzzentrum Universität Leipzig, Leipzig

56127

Az Osp Univ Pisana, Pisa

Unknown

Rigshospitalet, Copenhagen

Clinique Pasteur, Toulouse

Erasmus MC - Thorax Center, Rotterdam

Royal Sussex County Hospital, Brighton

The General Infirmary, Leeds

Oxford John Radcliffe Hospital, Oxford

New Cross Hospital, Wolverhampton

00290

University Helsinki, Helsinki

H91 YR71

Galway University Hospital, Galway

SE-221 85

University of Lund, Lund

BT12 6BA

Royal Victoria Belfast, Belfast