VAscular Closure for Cardiac Ablation Registry (VACCAR) (VACCAR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03546439 |
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Recruitment Status :
Completed
First Posted : June 6, 2018
Results First Posted : March 11, 2022
Last Update Posted : March 11, 2022
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| Condition or disease |
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| Atrial Fibrillation |
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 [Patient Registry] |
| Actual Enrollment : | 434 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Days |
| Official Title: | VAscular Closure for Cardiac Ablation Registry (VACCAR) |
| Actual Study Start Date : | October 25, 2017 |
| Actual Primary Completion Date : | May 24, 2019 |
| Actual Study Completion Date : | May 24, 2019 |
- Hemostasis [ Time Frame: 2 days ]Time to achieve hemostasis measured in minutes
- Ambulation [ Time Frame: 2 days ]Time to ambulate following hemostasis measured in hours
- Complications [ Time Frame: 2 days ]Number of bleeding and vascular complications
- Hospital Stay [ Time Frame: 2 days ]Length of hospital stay in hours
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546439
| United States, Missouri | |
| Saint Luke's Hospital of Kansas City | |
| Kansas City, Missouri, United States, 64111 | |
| Principal Investigator: | Sanjaya Gupta, MD | Saint Luke's Health System |
Documents provided by Saint Luke's Health System:
Publications:
| Responsible Party: | Saint Luke's Health System |
| ClinicalTrials.gov Identifier: | NCT03546439 |
| Other Study ID Numbers: |
VACCAR |
| First Posted: | June 6, 2018 Key Record Dates |
| Results First Posted: | March 11, 2022 |
| Last Update Posted: | March 11, 2022 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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atrial fibrillation vascular closure |
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |