NCT02031302 - RESPOND Post Market Study | Biotech Hunter

Enrollment

1,064

Participants

Timeline

Start Date

May 27, 2014

Primary Completion Date

April 4, 2017

Study Completion Date

May 18, 2021

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.

Trial Locations (41)

3240

Waikato Hospital, Hamilton

3430

Dept. of Cardiology Sint-Antonius ziekenhuis, Nieuwegein

5021

Haukeland universitetssjukehus, Bergen

10249

Vivantes Klinikum im Friedrichshain, Berlin

Universitätsklinikum Rostock, Rostock

13353

Charité Campus Virchow Klinikum, Berlin

20011

Policlinica Gipuzkoa, San Sebastián

20132

Ospedale San Raffaele, Milan

20149

IRCC Policlinico San Donato, Milan

20521

Turku University Hospital, Turku

23795

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH, Bad Segeberg

24105

Deutsches Herzzentrum Berlin, Berlin

28046

Hospital Universitario La Paz, Madrid

35100

Azienda Ospedaliera Universtitaria di Padova, Padua

49100

Rabin Medical Center, Petah Tikva

53105

Universitätsklinikum Bonn, Bonn

53113

Herz- und Gefäß-Klinik Bonn, Bonn

53721

HELIOS Clinic, Siegburg

56124

Azienda Ospedaliera Universtiatia Pisana (AOUP) Ospedale Cisanello, Pisa

69120

Universitätsklinikum Ulm, Ulm

76133

Krankenhaus d. Barmherzigen Brüder, Trier

80636

Deutsches Herzzentrum München, Munich

81377

University Hospital Munich, Munich

Unknown

Fundacion Cardiovascular de Colombia, Floridablanca

Angiografia de Occidente S.A., Santiago de Cali

Asklepios Klinik St. Georg, Hamburg

Erasmus Medical Center, Rotterdam

00290 HUS

Helsinki University Central Hospital/Meilahti Hospital, Helsinki

04289

Herzzentrum Universitat Leipzig, Leipzig

61-848

I Klinika Kardiologii Uniwersytetu Medycznego W Poznaiu, Poznan

04-628

National Institute of Cardiology, Warsaw

413 45

Sahlgrenska University Hospital, Gothenburg

CH-3010

INSELSPITAL - Universitätsspital Bern, Bern

OX3 9DU

John Radcliffe Infirmary Oxford II, Oxford

BN2 5BE

Royal Sussex County Hospital, Brighton

LS1 3EX

Leeds Teaching Hospitals NHS, Leeds

LE3 9QP

Glenfield Hospital, Leicester

SE1 7EH

Clinical Trials Practitioner, London

SE5 9RS

King's College Hospital London, London

SW17 0QT

Cardiovascular & Cell Sciences Research Institute, London

WV10 0QP

New Cross Hospital, Wolverhampton