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Accelerated Ambulation After Vascular Access Closure Device

Angioseal Groin Management After Left Heart Catheterization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03142126
Enrollment
28
Registered
2017-05-05
Start date
2014-08-06
Completion date
2015-09-05
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Angiography, Heart Catheterization

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.

Interventions

DEVICEEarly ambulation with Angioseal closure device

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

Sponsors

Providence Hospital
CollaboratorOTHER
Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Eligible patients will receive early ambulation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients undergoing diagnostic left heart catheterization.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Failure of device to achieve hemostasis20 minutes after procedureContinued bleeding after deployment prior to discharge

Secondary

MeasureTime frameDescription
Pseudoaneurysm7-10 days after dischargeClinical assessment in office follow-up visit
Groin hematoma7-10 days after dischargeClinical assessment in office follow-up visit, 7-10 days after discharge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026