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Dedicated Sheath Feasibility Study — BAV  

Aortic Stenosis Clinical Trial

Official title:
A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty

Clinical Trial 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).

Clinical Trial Description

This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required.

During the study, the patient will undergo the following tests:

- Physical examination (includes blood pressure, age, height, weight).

- Echo assessments prior to procedure.

- Hemodynamic study prior and post BAV.

- Full blood count

- Angiography ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02617524
Study type Interventional
Source Valve Medical
Contact Mor Buchshtav, M.Sc.
Phone 972 3 7679000
Email morb@medinol.com
Status Not yet recruiting
Phase N/A
Start date January 2016
Completion date August 2016
View Details
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