Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
NCT Number: NCT03546439
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Kansas City, Missouri, 64111, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 days
Time to achieve hemostasis measured in minutes
Time frame: 2 days
Time to ambulate following hemostasis measured in hours
Time frame: 2 days
Number of bleeding and vascular complications
Time frame: 2 days
Length of hospital stay in hours
Saint Luke's Health System
Other
Acronym: VACCAR
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.
Published trials that share one or more normalized conditions with this study.
NCT05820295
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial DetailsNCT05993897
Arrhythmias, Cardiac, Atrial Fibrillation
Aswān, Aswan Governorate, Egypt
View Trial DetailsNCT05357690
Arrhythmias, Cardiac, Atrial Fibrillation
Rochester, Minnesota, United States
View Trial DetailsNCT05164718
Arrhythmias, Cardiac, Atrial Fibrillation
Drammen, Norway
View Trial Details