NCT03546439|CompletedResults
VAscular Closure for Cardiac Ablation Registry (VACCAR)
VACCAR
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VACCAR
Sponsor study identifier
observational
434
1 country
1
Study Start
October 25, 2017
Actual (reported)Primary Completion
May 24, 2019
Actual (reported)Study Completion
May 24, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 24, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2017
Actual (reported)May 21, 2018
Actual (reported)June 6, 2018
Actual (reported)May 24, 2019
Actual (reported)May 24, 2019
Actual (reported)March 11, 2022
Actual (reported)Hemostasis
Time to achieve hemostasis measured in minutes
2 days
Ambulation
Time to ambulate following hemostasis measured in hours
2 days
Complications
Number of bleeding and vascular complications
2 days
Hospital Stay
Length of hospital stay in hours
2 days
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
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
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.
Koreny 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.
Single Center, non-randomized
Sanjaya Gupta, MD
Saint Luke's Health System
434 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2018
First Posted
June 6, 2018
Study Start
October 25, 2017
Actual (reported)Atrial Fibrillation Screening and Education Study
Contact the study team to confirm eligibility.
Biancari 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.
Nikolsky 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.
Schulz-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.
Vaitkus 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.
Maraj 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.
Noguchi 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.
Duffin 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.
Aytemir 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.
Abo-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.
Primary Completion
May 24, 2019
Actual (reported)Study Completion
May 24, 2019
Actual (reported)Last Updated
March 11, 2022
Results First Posted
March 11, 2022
Record last verified: 2021-12
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