Brief Title
Dedicated Sheath Feasibility Study
Official Title
A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty
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 Type
Interventional
Primary Outcome
Device success
Condition
Aortic Stenosis
Intervention
Valve Medical Dedicated Sheath version 00
Study Arms / Comparison Groups
Valve Medical Dedicated Sheath
Description: Valve Medical Dedicated Sheath version 00
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
15
Start Date
January 2016
Completion Date
August 2016
Primary Completion Date
July 2016
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 972 3 7679000, [email protected]
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT02617524
Organization ID
CLICL 01446
Responsible Party
Sponsor
Study Sponsor
Valve Medical
Collaborators
Medinol Ltd.
Study Sponsor
, ,
Verification Date
January 2016