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

NCT02202434 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1425

Last updated 2021-12-17

Study results available
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Summary

The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ 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.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Lotus Valve System

Procedure: Transcatheter aortic valve replacement (TAVR)

DEVICE

CoreValve/Evolut R Transcatheter Aortic Valve Replacement System

Procedure: Transcatheter aortic valve replacement (TAVR)

DEVICE

LOTUS Edge Valve System

Procedure: Transcatheter aortic valve replacement (TAVR)

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • David Rizik, MD · Scottsdale Healthcare - Shea

  • Michael J Reardon, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-22
Primary Completion
2017-03-08
Completion
2021-05-21

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202434 on ClinicalTrials.gov