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Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.
The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates, achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge. Manual compression (MC) the current standard of care, requires bedrest, often up to 8 hours. This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters.
Other methods of vascular closure include figure-of-eight (F-8) a, subcutaneous suture or Z-stitch or fellow's stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures. One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis. In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma, bleeding was also noted to be lower in F-8 group.
In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Figure-of-eight (F-8) suture | This is the group of subjects for whom Figure-of-eight (F-8) suture is used for their venous closure. |
| |
| Subjects with LockeT Device | This is the group of subjects for whom LockeT device is used for their venous closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous Closure | Device | Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of LockeT device - Time to no oozing/hemostasis | To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours) | 1 week |
| Effectiveness of LockeT device - Time to Ambulate | To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours) | 1 week |
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Inclusion Criteria:
All participants must meet the following criteria to be included in this study.
Exclusion Criteria:
If a subject meet any of the following criteria will be excluded from study participation.
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The study population will include who underwent AF ablation and required F-8 or LockeT post procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donita Atkins | Contact | 816-651-1969 | datkins@kchrf.com |
| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy, MD | Kansas City Heart Rhythm Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City Heart Rhythm Institute - Roe Clinic | Overland Park | Kansas | 66211 | United States | ||
| Overland Park Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31971899 | Background | Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30. | |
| 32638389 |
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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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| Overland Park |
| Kansas |
| 66215 |
| United States |
|
| Background |
| Mujer MT, Al-Abcha A, Flores J, Saleh Y, Robinson P. A comparison of figure-of-8-suture versus manual compression for venous access closure after cardiac procedures: An updated meta-analysis. Pacing Clin Electrophysiol. 2020 Aug;43(8):856-865. doi: 10.1111/pace.14008. Epub 2020 Jul 20. |
| 31001767 | Background | Atti V, Turagam MK, Garg J, Alratroot A, Abela GS, Rayamajhi S, Lakkireddy D. Efficacy and safety of figure-of-eight suture versus manual pressure for venous access closure: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2020 Apr;57(3):379-385. doi: 10.1007/s10840-019-00547-6. Epub 2019 Apr 18. |
| 32308550 | Background | Jensen CJ, Schnur M, Lask S, Attanasio P, Gotzmann M, Kara K, Hanefeld C, Mugge A, Wutzler A. Feasibility of the Figure-of-8-Suture as Venous Closure in Interventional Electrophysiology: One Strategy for All? Int J Med Sci. 2020 Apr 6;17(7):965-969. doi: 10.7150/ijms.42593. eCollection 2020. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |