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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Luebeck

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

Treatment groups

270 Participants
are divided into 2 treatment groups

Sponsors and collaborators