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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02617524

Acronym

BAV

Enrollment

Registered

2015-12-01

Start date

2016-01-31

Completion date

2016-08-31

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

dedicated sheath

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

Interventions

DEVICEValve Medical Dedicated Sheath version 00

The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Device success	Outcome measures will be assessed at 1, 6 and 24 hours post procedure.
Procedure Safety: Adverse Event Assessment for device related and unrelated events	Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure.

Countries

Israel

Contacts

Primary ContactMor Buchshtav, M.Sc.

morb@medinol.com972 3 7679000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026