Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
Recruiting · NCT06598280 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Luebeck
View the official record on ClinicalTrials.gov →Interventions studied
Atrial Fibrillation with femoral closure using closing systemAtrial Fibrillation with femoral closure using figure-of-eight stitch
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Klinik für Rhythmologie - Lübeck, Schleswig-Holstein, Germany