Dedicated Sheath Feasibility Study

Not Applicable

• Conditions: Aortic Stenosis
• Interventions: Device: Valve Medical Dedicated Sheath version 00

• Registration Number: NCT02617524
• Lead Sponsor: Valve Medical

Brief 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

Study Timeline

• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Status Verified: 2016-01
• Study Start: 2016-01
• Last Update Submitted: 2016-01-17
• Last Update Posted: 2016-01-20
• Primary Completion: 2016-07
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age ≥ 18 years.
• Patient understands the implications of participating in the study and provides written informed consent.
• The patient has an indication for balloon aortic valvuloplasty (BAV).

Exclusion Criteria

• Peripheral vessel anatomy or peripheral vascular disease that would preclude the insertion of the 12 Fr. sheath.
• Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valve Medical Dedicated Sheath	Valve Medical Dedicated Sheath version 00	Valve Medical Dedicated Sheath version 00

Primary Outcome Measures

Name	Time	Method
Device success	Outcome measures will be assessed at 1, 6 and 24 hours post procedure.
Procedure Safety: Adverse Event Assessment for device related and unrelated events	Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure.

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel