NCT02617524

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Valve Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Valve Medical Dedicated Sheath version 00	The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2015-12-01
• Last updated: 2016-01-20

Locations

1 site across 1 country: Israel