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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures
Hadassah Medical Center
Jerusalem, Israel
Device success
Time frame: Outcome measures will be assessed at 1, 6 and 24 hours post procedure.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.