Atrial FibrillationVACCARNCT03546439
VAscular Closure for Cardiac Ablation Registry (VACCAR)
An observational study of Atrial Fibrillation, run by Saint Luke's Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 434 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 24 May 2019
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, vascular closure
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis
Time to achieve hemostasis measured in minutes
Measured: 2 days
Ambulation
Time to ambulate following hemostasis measured in hours
Measured: 2 days
Complications
Number of bleeding and vascular complications
Measured: 2 days
Hospital Stay
Length of hospital stay in hours
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start25 Oct 2017
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 434 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Sanjaya Gupta, MD, Principal investigator, Saint Luke's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546439
- Sponsor's protocol ID
- VACCAR
- Acronym
- VACCAR
- Status last verified
- Dec 2021
- First submitted
- 21 May 2018
- Last updated
- 11 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: the second decade. J Am Coll Cardiol. 2007 Oct 23;50(17):1617-26. doi: 10.1016/j.jacc.2007.07.028.
PubMed 17950141Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004 Jan 21;291(3):350-7. doi: 10.1001/jama.291.3.350.
PubMed 14734598Biancari F, D'Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010 Apr;159(4):518-31. doi: 10.1016/j.ahj.2009.12.027.
PubMed 20362708Nikolsky E, Mehran R, Halkin A, Aymong ED, Mintz GS, Lasic Z, Negoita M, Fahy M, Krieger S, Moussa I, Moses JW, Stone GW, Leon MB, Pocock SJ, Dangas G. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol. 2004 Sep 15;44(6):1200-9. doi: 10.1016/j.jacc.2004.06.048.
PubMed 15364320Schulz-Schupke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Bottiger C, Groha P, Bradaric C, Schmidt R, Bott-Flugel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305.
PubMed 25399273Vaitkus PT. A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. J Invasive Cardiol. 2004 May;16(5):243-6.
PubMed 15152128Maraj I, Budzikowski AS, Ali W, Mitre CA, Kassotis J. Use of vascular closure device is safe and effective in electrophysiological procedures. J Interv Card Electrophysiol. 2015 Aug;43(2):193-5. doi: 10.1007/s10840-015-0005-5. Epub 2015 Apr 29.
PubMed 25921347Noguchi T, Miyazaki S, Yasuda S, Baba T, Sumida H, Morii I, Daikoku S, Goto Y, Nonogi H. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg. 2000 May;19(5):451-5. doi: 10.1053/ejvs.1999.1071.
PubMed 10828223Duffin DC, Muhlestein JB, Allisson SB, Horne BD, Fowles RE, Sorensen SG, Revenaugh JR, Bair TL, Lappe DL. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001 May;13(5):354-62.
PubMed 11385148Aytemir K, Canpolat U, Yorgun H, Evranos B, Kaya EB, Sahiner ML, Ozer N. Usefulness of 'figure-of-eight' suture to achieve haemostasis after removal of 15-French calibre femoral venous sheath in patients undergoing cryoablation. Europace. 2016 Oct;18(10):1545-1550. doi: 10.1093/europace/euv375. Epub 2015 Dec 23.
PubMed 26705565Abo-Salem E, Miller B, Wexler L, Attari M. Vascular Closure Devices for venous accesses in anticoagulated patients after catheter ablation for Atrial Fibrillation. JACC March 17,2015. Volume 65, Issue 10S.
Martin JL, Pratsos A, Magargee E, Mayhew K, Pensyl C, Nunn M, Day F, Shapiro T. A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: the CAP trial. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):1-5. doi: 10.1002/ccd.21333.
PubMed 18098171
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAscular Closure for Cardiac Ablation Registry (VACCAR)
- ClinicalTrials.gov ID
- NCT03546439
- Acronym / sponsor ID
- VACCAR / VACCAR
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, vascular closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 11 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17950141Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: the second decade. J Am Coll Cardiol. 2007 Oct 23;50(17):1617-26. doi: 10.1016/j.jacc.2007.07.028.
- Background: PubMed 14734598Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004 Jan 21;291(3):350-7. doi: 10.1001/jama.291.3.350.
- Background: PubMed 20362708Biancari F, D'Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010 Apr;159(4):518-31. doi: 10.1016/j.ahj.2009.12.027.
- Background: PubMed 15364320Nikolsky E, Mehran R, Halkin A, Aymong ED, Mintz GS, Lasic Z, Negoita M, Fahy M, Krieger S, Moussa I, Moses JW, Stone GW, Leon MB, Pocock SJ, Dangas G. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol. 2004 Sep 15;44(6):1200-9. doi: 10.1016/j.jacc.2004.06.048.
- Background: PubMed 25399273Schulz-Schupke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Bottiger C, Groha P, Bradaric C, Schmidt R, Bott-Flugel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305.
- Background: PubMed 15152128Vaitkus PT. A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. J Invasive Cardiol. 2004 May;16(5):243-6.
- Background: PubMed 25921347Maraj I, Budzikowski AS, Ali W, Mitre CA, Kassotis J. Use of vascular closure device is safe and effective in electrophysiological procedures. J Interv Card Electrophysiol. 2015 Aug;43(2):193-5. doi: 10.1007/s10840-015-0005-5. Epub 2015 Apr 29.
- Background: PubMed 10828223Noguchi T, Miyazaki S, Yasuda S, Baba T, Sumida H, Morii I, Daikoku S, Goto Y, Nonogi H. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg. 2000 May;19(5):451-5. doi: 10.1053/ejvs.1999.1071.
- Background: PubMed 11385148Duffin DC, Muhlestein JB, Allisson SB, Horne BD, Fowles RE, Sorensen SG, Revenaugh JR, Bair TL, Lappe DL. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001 May;13(5):354-62.
- Background: PubMed 26705565Aytemir K, Canpolat U, Yorgun H, Evranos B, Kaya EB, Sahiner ML, Ozer N. Usefulness of 'figure-of-eight' suture to achieve haemostasis after removal of 15-French calibre femoral venous sheath in patients undergoing cryoablation. Europace. 2016 Oct;18(10):1545-1550. doi: 10.1093/europace/euv375. Epub 2015 Dec 23.
- BackgroundAbo-Salem E, Miller B, Wexler L, Attari M. Vascular Closure Devices for venous accesses in anticoagulated patients after catheter ablation for Atrial Fibrillation. JACC March 17,2015. Volume 65, Issue 10S.
- Background: PubMed 18098171Martin JL, Pratsos A, Magargee E, Mayhew K, Pensyl C, Nunn M, Day F, Shapiro T. A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: the CAP trial. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):1-5. doi: 10.1002/ccd.21333.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjaya Gupta, MD principal investigator
Saint Luke's Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Saint Luke's Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis (time frame: 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546439, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.