VAscular Closure for Cardiac Ablation Registry (VACCAR)

NCT03546439 | Completed Results

• 1 other identifier: VACCAR
• Study Type: observational
• Target: 434
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; vascular closure

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saint Luke's Health System: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (12)

• 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.

  PMID: 17950141 BACKGROUND

• 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.

  PMID: 14734598 BACKGROUND

• 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.

  PMID: 20362708 BACKGROUND

• 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.

  PMID: 15364320 BACKGROUND

• 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.

  PMID: 25399273 BACKGROUND

• 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.

  PMID: 15152128 BACKGROUND

• 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.

  PMID: 25921347 BACKGROUND

• 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.

  PMID: 10828223 BACKGROUND

• 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.

  PMID: 11385148 BACKGROUND

• 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.

  PMID: 26705565 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18098171 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Single Center, non-randomized

Results Point of Contact

• Title: Sanjaya Gupta, MD
• Organization: Saint Luke's Hospital of Kansas City

sgupta@saint-lukes.org

8169311883

Study Officials

• Sanjaya Gupta, MD

  Saint Luke's Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 6, 2018
• Study Start: October 25, 2017
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: March 11, 2022
• Results First Posted: March 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)