Dedicated Sheath Feasibility Study

NCT ID: NCT02617524

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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

Conditions

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Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Valve Medical Dedicated Sheath

Valve Medical Dedicated Sheath version 00

Group Type EXPERIMENTAL

Valve Medical Dedicated Sheath version 00

Intervention Type DEVICE

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

Interventions

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Valve Medical Dedicated Sheath version 00

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medinol Ltd.

INDUSTRY

Sponsor Role collaborator

Valve Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Mor Buchshtav, M.Sc.

Role: CONTACT

972 3 7679000 ext. 3514

Facility Contacts

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Galina Levin

Role: primary

972 2 6778914

Other Identifiers

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CLICL 01446

Identifier Type: -

Identifier Source: org_study_id

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