Accelerated Ambulation After Vascular Access Closure Device

Coronary Angiography Clinical Trial

Official title:

Angioseal Groin Management After Left Heart Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142126
• Other study ID #: 548976
• Status: Completed
• Phase: N/A
• First received: May 3, 2017
• Last updated: May 3, 2017
• Start date: August 6, 2014
• Est. completion date: September 5, 2015

Study information

• Verified date: May 2017
• Source: Ascension St John Providence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 5, 2015
• Est. primary completion date: August 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Patients undergoing diagnostic left heart catheterization.

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

Related Conditions & MeSH terms

• Coronary Angiography
• Heart Catheterization

Intervention

Device:
• Early ambulation with Angioseal closure device
To reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ascension St John Providence	Providence Hospital

References & Publications (2)

Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj A, Niemelä M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group.. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4. Erratum in: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30. — View Citation

Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of device to achieve hemostasis	Continued bleeding after deployment prior to discharge	20 minutes after procedure
Secondary	Pseudoaneurysm	Clinical assessment in office follow-up visit	7-10 days after discharge
Secondary	Groin hematoma	Clinical assessment in office follow-up visit, 7-10 days after discharge	7-10 days after discharge