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

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

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).

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.

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