Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fib
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 com
| Condition(s) | Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Luebeck |
| Locations | Lübeck, Schleswig-Holstein, Germany |
| Start date | 2025-02-20 |
| NCT ID | NCT06598280 |
| Official listing | https://clinicaltrials.gov/study/NCT06598280 |