Dedicated Sheath Feasibility Study (BAV)

Valve Medical

Status

Unknown

Conditions

Aortic Stenosis

Treatments

Device: Valve Medical Dedicated Sheath version 00

Study type

Interventional

Funder types

Industry

Identifiers

NCT02617524

CLICL 01446

Details and patient eligibility

About

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).

Full 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

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.