Status:
RECRUITING
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
Lead Sponsor:
University of Luebeck
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 me...
Detailed Description
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' clini...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06598280
Start Date
February 20 2025
End Date
March 15 2028
Last Update
April 8 2025
Active Locations (1)
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1
Klinik für Rhythmologie
Lübeck, Schleswig-Holstein, Germany, 23538