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OpenTrials
Completed

NCT Number: NCT03142126

Accelerated Ambulation After Vascular Access Closure Device

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.

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Key information

Conditions

Coronary Angiography Heart Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing diagnostic left heart catheterization.

Exclusion criteria

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

Treatment and study plan

Early ambulation with Angioseal closure device

Device

To reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy

Other names: Angioseal

Primary outcomes

  1. Failure of device to achieve hemostasis

    Time frame: 20 minutes after procedure

    Continued bleeding after deployment prior to discharge

Secondary outcomes

  1. Pseudoaneurysm

    Time frame: 7-10 days after discharge

    Clinical assessment in office follow-up visit

  2. Groin hematoma

    Time frame: 7-10 days after discharge

    Clinical assessment in office follow-up visit, 7-10 days after discharge

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Providence Hospital

Registry information

Official study title

Angioseal Groin Management After Left Heart Catheterization

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 5, 2017
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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