A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Device success
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported