Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation

Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study

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).

The aim of the study is to prove that the use of a SDD protocol does not lead to a higher rate of adverse events (minor and major), unplanned medical visits (emergency department or outpatients' clinic) and unplanned readmissions, while substantially reducing the costs associated with the medical care and increasing the comfort of the patients on a period of 30 days, when compared to ONS and manual compression ± figure-of-eight suture. Moreover, the safety, efficiency, and feasibility of the SDD protocol should be proven during a follow-up (FU) period of 12 months. The definition of endpoints will be trained in all participating study sites to preserve consistency.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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