Dedicated Sheath Feasibility Study (BAV)
Primary Purpose
Aortic Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Valve Medical Dedicated Sheath version 00
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis focused on measuring dedicated sheath
Eligibility Criteria
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.
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valve Medical Dedicated Sheath
Arm Description
Valve Medical Dedicated Sheath version 00
Outcomes
Primary Outcome Measures
Device success
Procedure Safety: Adverse Event Assessment for device related and unrelated events
Secondary Outcome Measures
Full Information
NCT ID
NCT02617524
First Posted
November 24, 2015
Last Updated
January 17, 2016
Sponsor
Valve Medical
Collaborators
Medinol Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02617524
Brief Title
Dedicated Sheath Feasibility Study
Acronym
BAV
Official Title
A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valve Medical
Collaborators
Medinol Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
dedicated sheath
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Valve Medical Dedicated Sheath
Arm Type
Experimental
Arm Description
Valve Medical Dedicated Sheath version 00
Intervention Type
Device
Intervention Name(s)
Valve Medical Dedicated Sheath version 00
Intervention Description
The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures
Primary Outcome Measure Information:
Title
Device success
Time Frame
Outcome measures will be assessed at 1, 6 and 24 hours post procedure.
Title
Procedure Safety: Adverse Event Assessment for device related and unrelated events
Time Frame
Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mor Buchshtav, M.Sc.
Phone
972 3 7679000
Ext
3514
Email
morb@medinol.com
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galina Levin
Phone
972 2 6778914
Email
lenving@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Haim Danenberg, M.D., PhD
12. IPD Sharing Statement
Learn more about this trial
Dedicated Sheath Feasibility Study
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