About this trial
Prospective, randomized, controlled, multicentre study to compare the safety and efficacy of a Same Day Discharge (SDD) protocol in combination with a Perclose ProStyle (PPS) /ProGlide (PPG) suture mediated vascular closure device to the current gold standard: an overnight stay (ONS) protocol associated with manual compression ± figure-of-eight suture for the patients receiving interventional pulmonary vein isolation (PVI).
Eligibility criteria
Qualifiers
Patients age >=18 years
Elective catheter ablation for atrial fibrillation using 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites, independent of the energy source use
Disqualifiers
Active systemic or cutaneous infection, or inflammation in vicinity of the groin
Platelet count < 50,000 cells/mm3
Body mass index (BMI) > 45 kg/m2 or < 18 kg/m2
Trial design
Treatments tested in this trial
- Atrial Fibrillation with femoral closure using closing system
- Atrial Fibrillation with femoral closure using figure-of-eight stitch