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The Conveyor Study

NCT03893578 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-04-05

No results posted yet for this study

Summary

To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral valve replacement or repair (failing bioprosthetic mitral valve) who are candidates for mitral valve-in-valve procedure.

Conditions

  • Mitral Valve Insufficiency
  • Mitral Valve Disease
  • Mitral Valve Regurgitation
  • Heart Failure

Interventions

DEVICE

Mitral valve-in-valve

The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location.

Sponsors & Collaborators

  • Synecor, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2019-12-31
Completion
2020-02-29
FDA Device
Yes

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Entities

Diseases

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 NCT03893578 on ClinicalTrials.gov