Clinical Trials Logo
  1. Home
  2. Aortic Stenosis
  3. NCT02491255

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

Aortic Stenosis Clinical Trial

Official title:
REPRISE Japan: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Clinical Evaluation in Japan

Clinical Trial Summary

The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at high or extreme risk for surgical valve replacement.

Clinical Trial Description

A prospective, multicenter trial designed to confirm that the safety and effectiveness of the Lotus Valve System in the Japanese medical environment are consistent with the REPRISE III results for TAVR in symptomatic subjects who have calcific, severe native aortic stenosis and who are at extreme or high risk for surgical valve replacement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02491255
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date June 22, 2015
Completion date September 13, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Completed NCT03332745 - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting NCT06008080 - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting NCT06055751 - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting NCT04815785 - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis N/A
Terminated NCT02202434 - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement N/A
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting NCT02903420 - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) N/A
Completed NCT02629328 - CardioCel Tri-leaflet Repair Study N/A
Completed NCT02306226 - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Completed NCT01676727 - ADVANCE Direct Aortic Study
Withdrawn NCT01648309 - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation N/A
Completed NCT01422044 - Risk Prediction in Aortic Stenosis N/A
Withdrawn NCT00774657 - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography N/A
Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
Terminated NCT05070130 - OpSens PRIME CLASS
Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Completed NCT04157920 - Impact of Predilatation Between Self-expanding Valves N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting NCT05893082 - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR N/A