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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sanjaya Gupta, MD | Saint Luke's Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17950141 | Background | 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. | |
| 14734598 | 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. |
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Because this is a registry, there are no randomization procedures. The choice of closure method was chosen by each subject's physicians. The subjects were approached for consent after the procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Figure of 8 | Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures |
| FG001 | Manual Compression | Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures |
| FG002 | Perclose Device | Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Figure of 8 | Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures |
| BG001 | Manual Compression | Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemostasis | Time to achieve hemostasis measured in minutes | There were 434 patients included | Posted | Mean | Full Range | minutes | 2 days |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Figure of 8 | Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Systematic Assessment | large hematoma at the access site requiring 3 units of blood transfusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Systematic Assessment | Minor hematomas that did not require a blood transfusion |
Single Center, non-randomized
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjaya Gupta, MD | Saint Luke's Hospital of Kansas City | 8169311883 | sgupta@saint-lukes.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2018 | Dec 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 20362708 | 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. |
| 15364320 | 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. |
| 25399273 | 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. |
| 15152128 | 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. |
| 25921347 | 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. |
| 10828223 | 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. |
| 11385148 | 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. |
| 26705565 | 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. |
| 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. |
| 18098171 | 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. |
| BG002 | Perclose Device | Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
|
|
| Primary | Ambulation | Time to ambulate following hemostasis measured in hours | Posted | Median | Full Range | Hours | 2 days |
|
|
|
| Primary | Complications | Number of bleeding and vascular complications | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Primary | Hospital Stay | Length of hospital stay in hours | Posted | Median | Full Range | hours | 2 days |
|
|
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| Post-Hoc | Perception of Pain | Patient's perception of pain is measured using a 5 point Likert scale, range from 1 to 5 with higher scores indicating higher level of pain | Posted | Median | Full Range | units on a scale | 2 days |
|
|
|
| Post-Hoc | Patient Satisfaction | Patient satisfaction is measured using a 5 point Likert scale with range from 1 to 5 with higher scores indicating greater patient satisfaction | Posted | Median | Full Range | units on a scale | 2 days |
|
|
|
| Post-Hoc | Need for Manual Compression | Patient's need for manual compression is expressed as number of patients as a whole number | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Post-Hoc | Use of Protamine Sulfate | Use of protamine sulfate is expressed as a whole number | Posted | Count of Participants | Participants | 2 days |
|
|
|
| 0 |
| 203 |
| 0 |
| 203 |
| 3 |
| 203 |
| EG001 | Manual Compression | Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures | 0 | 156 | 1 | 156 | 4 | 156 |
| EG002 | Perclose Device | Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures | 0 | 75 | 0 | 75 | 3 | 75 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Male |
|