NCT05563142

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: University of Luebeck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	deploying vascular closure device versus manual compression	patients will be randomized to either group 1 or group 2 in a 1:1 ratio:

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-10-03
• Last updated: 2024-07-01

Locations

3 sites across 1 country: Germany