Star-Close Early Ambulation Trial
Not Applicable
Completed
- Conditions
- Cardiovascular Disease
- Interventions
- Behavioral: Walking
- Registration Number
- NCT00590798
- Lead Sponsor
- Ernest Mazzaferri
- Brief Summary
To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Walking Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.
- Primary Outcome Measures
Name Time Method Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization 7 days post procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States