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REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects

NCT03618095 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2022-12-27

Study results available
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Summary

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

LOTUS Edge Valve System

TAVR with the LOTUS Edge Valve System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Christopher U. Meduri, MD, MPH · Piedmont Heart Institute

  • Vinod H. Thourani, MD · Piedmont Heart Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2021-03-30
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States
  • Australia

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 NCT03618095 on ClinicalTrials.gov