Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation

Study Overview
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Brief Summary
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Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).

Detailed Description
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The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.

Official Title
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Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: deploying vascular closure device versus manual compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age >18 Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites Exclusion Criteria: Active systemic or cutaneous infection, or inflammation in vicinity of the groin Platelet count < 100,000 cells/mm3 BMI > 45 kg/m2 or < 20 kg/m2 Attempted femoral arterial access or inadvertent arterial puncture Procedural complications that interfered with routine recovery, ambulation, or discharge times Incorrect sheath placement Intraprocedural bleeding or thrombotic complications Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Perclose ProStyle closure<br>50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis | Procedure: deploying vascular closure device versus manual compression<br>* patients will be randomized to either group 1 or group 2 in a 1:1 ratio:<br>|
| Active Comparator: Group manual compression<br>50 patients treated with manual compression and one figure of eight suture | Procedure: deploying vascular closure device versus manual compression<br>* patients will be randomized to either group 1 or group 2 in a 1:1 ratio:<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ambulation | elapsed time between removal of the final closure device or removal of the final sheath and when the patient can stand and walk 20 ft without evidence of venous re-bleeding from the femoral access site. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total post procedure time | elapsed time between removal of the last procedural device for the index procedure and when the patient was able to successfully ambulate | 6 hours | 
| time to hemostasis | elapsed time between removal of the closure device or the sheath and first observed and confirmed venous hemostasis, for each access site | 6 hours | 
| time to discharge eligibility | elapsed time between removal of the final closure device or final sheath and when the patient was eligible for hospital discharge based solely on the assessment of the access site, as determined by the medical team | 3 days | 
| time to discharge | elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution | 3 days | 
| time to closure eligibility | elapsed time between removal of the last procedural device for the index procedure and removal of the first closure device or first sheath | 6 hours | 
| Incidence of major adverse events | Incidence of major adverse events within 30 days after the procedure | 30 days | 
| Incidence of minor adverse events | Incidence of minor adverse events within 30 days after the procedure | 30 days | 
| Time to final hemostasis | Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications | 3 days |