Accelerated Ambulation After Vascular Access Closure Device

Study Overview
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Brief Summary
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The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early ambulation would be just as safe while improving cost and patient comfort.

Detailed Description
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Diagnostic left heart catheterization is the gold standard to assess coronary anatomy. A number of post procedure closure devices have been used in order to be able to ambulate patients after the procedure. Without closure device of the arterial sheath the typical time a patient must lay flat following a diagnostic left heart catheterization at Providence hospital is approximately six hours. This extended time of having to lie flat for the patient is both uncomfortable and time consuming for hospital employees. The Angioseal closure device is a vascular plug that has been approved by the FDA in order to seal the femoral artery arteriotomy and allow for a faster ambulation time after cardiac catheterization. Currently, the Angioseal device has been approved for ambulation times of 20 minutes after diagnostic left heart catheterization but a more conservative approach is typically used after device. A very common strategy after Angioseal is to keep the patient flat for 2 hours prior to ambulation and then to keep the patient another hour after ambulation for observation of the femoral site. While a conservative strategy may be considered safer to the operator the Angioseal device has already been approved for an early ambulation strategy. The goal of this study is to reaffirm the safety and efficacy of using Angioseal for early ambulation. If early ambulation is performed it could improve patient comfort and even reduce cost.

Official Title
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Angioseal Groin Management After Left Heart Catheterization

Conditions
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Coronary Angiography, Heart Catheterization

Intervention / Treatment
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* Device: Early ambulation with Angioseal closure device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing diagnostic left heart catheterization. Exclusion Criteria: Patients who do not meet criteria for Angioseal closure after diagnostic left heart catheterization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Eligible patients will receive early ambulation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Ambulation<br>To affirm the safety and efficacy of ambulation of 20 minutes after diagnostic left heart catheterization. | Device: Early ambulation with Angioseal closure device<br>* To reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy<br>* Other names: Angioseal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of device to achieve hemostasis | Continued bleeding after deployment prior to discharge | 20 minutes after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pseudoaneurysm | Clinical assessment in office follow-up visit | 7-10 days after discharge | 
| Groin hematoma | Clinical assessment in office follow-up visit, 7-10 days after discharge | 7-10 days after discharge |