Dedicated Sheath Feasibility Study

Aortic Stenosis Clinical Trial

— BAV  

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02617524
• Other study ID #: CLICL 01446
• Status: Not yet recruiting
• Phase: N/A
• First received: November 24, 2015
• Last updated: January 17, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: Valve Medical
• Contact: Mor Buchshtav, M.Sc.
• Phone: 972 3 7679000
• Email: morb[@]medinol.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• Valve Medical Dedicated Sheath version 00
The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Valve Medical	Medinol Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device success		Outcome measures will be assessed at 1, 6 and 24 hours post procedure.	No
Primary	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.	Yes