Reprise III Continued Access Study

REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

Reprise III Continued Access Study [NCT02202434]

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

Device: Lotus Valve System

Primary Investigator: Sarembock

Drug/Device Information
To evaluate the safety and effectiveness of the Lotus Valve System for transcatheter aortic valve replacement (TAVR)
Extreme or high risk for surgical valve replacement
Lotus Valve System is a transfemoral aortic valve replacement device that potentially has an enhanced ability to place the valve correctly at the first attempt, or reposition and retrieve the device
Nonrandomized
Boston Scientific Corporation
Major Inclusion and Exclusion
AVA of ≤ 1.0 or AVA index of < 0.6
Mean pressure gradient > 40 mm Hg or jet velocity > 4.0
STS score ≥ 8% (can be < 8 with another operative risk)
Aortic annulus size of ≥ 20 mm and ≤ 27 mm
No ejection fraction <20%
No GFR <20
No Hgb <9
No platelet count <50,000
No CVA or TIA within the past 6 months
No myocardial infarction within 30 days
Lotus devices sizes 23 mm, 25 mm, and 27 mm