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Dedicated Sheath Feasibility Study

NCT02617524 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-01-20

No results posted yet for this study

Summary

Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Valve Medical Dedicated Sheath version 00

The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures

Sponsors & Collaborators

  • Medinol Ltd.

    collaborator INDUSTRY

  • Valve Medical

    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
2016-01-31
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • Israel

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 NCT02617524 on ClinicalTrials.gov