Star-Close Early Ambulation Trial

NCT ID: NCT00590798

Last Updated: 2013-04-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-12-31

Brief Summary

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To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.

Detailed Description

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To confirm that patients who receive the Star-Close vascular closure system (VCS) after diagnostic cardiac catheterization can safely ambulate within 30 minutes of catheterization.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

Patient will walk within 30 minutes of vascular closure system procedure

Interventions

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Walking

Patient will walk within 30 minutes of vascular closure system procedure

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to for an outpatient left heart catheterization
* Catheterization through the femoral artery
* Able to ambulate at least 20 feet
* Able to receive the Star-Close Vascular Closure System
* Be a candidate for hospital discharge following catheterization

Exclusion Criteria

* Known peripheral arterial disease
* Blood pressure greater than 180/110
* Pregnant or lactating
* Anemic or low blood count
* Blood thinning medication within 5 days before catheterization
* Unable to walk 20 feet with out rest
* Complications during catheterization procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ernest Mazzaferri

OTHER

Sponsor Role lead

Responsible Party

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Ernest Mazzaferri

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Earnest L Mazzaferri Jr, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Medical Center, Division of Cardiovascular Medicine

Locations

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The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STRUT

Identifier Type: -

Identifier Source: org_study_id

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