CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Lotus Valve Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01383720
NCT01383720N/ACompleted
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REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

Boston Scientific Corporation·interventional·Posted Jun 28, 2011·Updated Jun 20, 2017

In Brief

A clinical study evaluating Lotus Valve System for Aortic Valve Stenosis and 2 related conditions. Completed, enrolled 11 participants across 3 sites.

Detailed Summary

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
CountriesAustralia
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2011
Enrollment StartApr 1, 2012
Primary CompletionMay 1, 2012
Study CompletionMay 9, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.0 years ago

Interventions

Lotus Valve Systemdevice

The Lotus Valve System includes the Lotus Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve, and the Lotus Delivery Catheter for guidance and placement.