Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation (Style-AF)

University of Luebeck

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Procedure: deploying vascular closure device versus manual compression

Study type

Interventional

Funder types

Other

Identifiers

NCT05563142

Style-AF

Details and patient eligibility

About

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).

Full 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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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