VAscular Closure for Cardiac Ablation Registry (VACCAR)

Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:October 25, 2017
End Date:October 31, 2020
Contact:Lisa Campbell, RN

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The objective of this registry is to find out if there is a difference in patient
satisfaction and rate of vascular and bleeding complications with use of Perclose Proglide
system or F08S for venous closure post atrial fibrillation and atrial flutter procedures in
comparison to manual compression.

Vascular Closure Devices (VCD) have been used to achieve hemostasis of arterial access sites
following cardiac catheterization procedures. There is extensive literature available
supporting the use of these devices for arterial access site closure, showing reduced time to
hemostasis, earlier ambulation and reduced length of hospital stay in comparison to manual
compression which is the traditional approach to achieve access site hemostasis. In contrast,
there is not significant evidence supporting the use of these devices for closure of femoral
venous access site, partly due to limited use of VCD in cardiac electrophysiology procedures,
such as catheter ablation for atrial fibrillation and atrial flutter. Another alternative to
manual compression, the Figure of 8 stitch has also been used to achieve vascular closure
follow catheter ablation of atrial fibrillation and atrial flutter, however it has not been
studied formally.

The aim of this registry is to better understand the 'real-world' utilization of VCD or
Figure of 8 stitch(F08S) in cardiac ablation procedures and to understand any potential
difference between VCD or F08S and manual compression. The outcomes of interest are vascular
access site complication rate, time to ambulation and patient perception of pain and overall
satisfaction, which is assessed via a survey. The hypothesis of this registry is that there
will be an increased patient satisfaction and decreased rate of vascular and bleeding
complications with use of either Perclose Proglide system or Figure of 8 stitch for venous
closure post atrial fibrillation ablation and atrial flutter ablation procedures in
comparison to standard manual compression.

The design will be a prospective observational registry collecting data on patients who
underwent catheter ablation for atrial fibrillation and atrial flutter, including
administration of a patient survey.

Inclusion Criteria:

- Patients undergoing a catheter ablation procedure (radiofrequency ablation or
cryoblation) to treat symptomatic paroxysmal atrial fibrillation or atrial flutter

- Patients willing to participate in a short written survey

Exclusion Criteria:

- Patients undergoing ablation for an arrhythmia other than atrial fibrillation/atrial
flutter or who are not candidates for an ablation procedure for treatment of atrial
fibrillation/atrial flutter

- Patients who are not able to read or understand the English language

- Patients who had recent access site complications within the same hospitalization

- Patients who have baseline thrombocytopenia (platelet count less than 80) or known
coagulopathy (INR > 1.5)
We found this trial at
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Phone: 816-932-0261
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
Kansas City, MO
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