VAscular Closure for Cardiac Ablation Registry (VACCAR) (VACCAR)

December 29, 2021 updated by: Saint Luke's Health System
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

434

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing a catheter ablation procedure (radiofrequency ablation or cryoablation) to treat symptomatic paroxysmal atrial fibrillation or atrial flutter at Saint Luke's Hospital of Kansas City

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemostasis
Time Frame: 2 days
Time to achieve hemostasis measured in minutes
2 days
Ambulation
Time Frame: 2 days
Time to ambulate following hemostasis measured in hours
2 days
Complications
Time Frame: 2 days
Number of bleeding and vascular complications
2 days
Hospital Stay
Time Frame: 2 days
Length of hospital stay in hours
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Sanjaya Gupta, MD, Saint Luke's Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

May 24, 2019

Study Completion (Actual)

May 24, 2019

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

June 1, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VACCAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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