Lotus Valve System

DEVICE6 trials

Sponsors

Boston Scientific Corporation, Second Affiliated Hospital, School of Medicine, Zhejiang University

Conditions

Aortic StenosisAortic Valve CalcificationAortic Valve DiseaseAortic Valve StenosisTranscatheter Aortic Valve Replacement

Phase 3

Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityAortic Valve Stenosis

Start: 2015-09-30End: 2020-12-31Target: 20Updated: 2015-09-01

Unknown Phase

REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

CompletedNCT01383720

Boston Scientific CorporationAortic Valve Calcification, Aortic Valve Disease, Aortic Valve Stenosis

Start: 2012-04-30End: 2017-05-09Updated: 2017-06-20

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

CompletedNCT01627691

Boston Scientific CorporationTranscatheter Aortic Valve Replacement

Start: 2012-10-08End: 2019-05-13Updated: 2020-05-12

RESPOND Post Market Study

CompletedNCT02031302

Boston Scientific CorporationAortic Valve Stenosis

Start: 2014-05-27End: 2021-05-18Updated: 2021-11-19

Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement

TerminatedNCT02202434

Boston Scientific CorporationAortic Stenosis

Start: 2014-09-22End: 2021-05-21Updated: 2021-12-17

Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)

CompletedNCT02491255

Boston Scientific CorporationAortic Stenosis

Start: 2015-06-22End: 2021-09-13Updated: 2021-09-28

Related Papers

Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR

JAMA Network Open2022-10-275 citations

Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement

Journal of the American Heart Association2020-08-2821 citations

Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial.

2019-10-2356 citations

Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves

JAMA Cardiology2019-02-2751 citations

Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort.

2019-01-0114 citations

Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk

Circulation2018-03-1225 citations

Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis

JAMA2018-01-02162 citations

1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study.

2016-02-0187 citations

Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study.

2014-09-01155 citations