CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,064 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/NCT02031302
NCT02031302N/ACompleted
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RESPOND: Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes

Boston Scientific Corporation·observational·Posted Jan 9, 2014·Updated Nov 19, 2021

In Brief

An observational study evaluating Lotus Valve System for Aortic Valve Stenosis. Completed, enrolled 1,064 participants across 41 sites in 13 countries.

Detailed Summary

The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesColombia, Finland, Germany, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 9, 2014
Enrollment StartMay 27, 2014
Primary CompletionApr 4, 2017
Study CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.5 years ago

Interventions

Lotus Valve Systemdevice

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.