VAscular Closure for Cardiac Ablation Registry (VACCAR)

Completed

Conditions: Atrial Fibrillation

Registration Number: NCT03546439

Lead Sponsor: Saint Luke's Health System

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 434

Inclusion Criteria

Patients undergoing a catheter ablation procedure (radiofrequency ablation or cryoablation) 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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ambulation	2 days	Time to ambulate following hemostasis measured in hours
Complications	2 days	Number of bleeding and vascular complications
Hemostasis	2 days	Time to achieve hemostasis measured in minutes
Hospital Stay	2 days	Length of hospital stay in hours