Accelerated Ambulation After Vascular Access Closure Device

Not Applicable

Completed

• Conditions: Heart Catheterization; Coronary Angiography
• Interventions: Device: Early ambulation with Angioseal closure device

• Registration Number: NCT03142126
• Lead Sponsor: Ascension South East Michigan

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-08-06
• Primary Completion: 2015-08-05
• Study Completion: 2015-09-05
• Status Verified: 2017-05
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients undergoing diagnostic left heart catheterization.

Exclusion Criteria

Patients who do not meet criteria for Angioseal closure after diagnostic left heart catheterization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early Ambulation	Early ambulation with Angioseal closure device	To affirm the safety and efficacy of ambulation of 20 minutes after diagnostic left heart catheterization.

Primary Outcome Measures

Name	Time	Method
Failure of device to achieve hemostasis	20 minutes after procedure	Continued bleeding after deployment prior to discharge

Secondary Outcome Measures

Name	Time	Method
Groin hematoma	7-10 days after discharge	Clinical assessment in office follow-up visit, 7-10 days after discharge
Pseudoaneurysm	7-10 days after discharge	Clinical assessment in office follow-up visit