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Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
Sponsor: University of Luebeck
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).
Official title: Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2025-02-20
Completion Date
2028-03-15
Last Updated
2025-04-08
Healthy Volunteers
No
Conditions
Interventions
Atrial Fibrillation with femoral closure using closing system
The ablation procedure will be performed under deep sedation/general anaesthesia as standard of care. Vital signs will be monitored. For patients on oral anticoagulation, the procedure will be performed according to the latest guidelines. For catheter access, sheaths will be placed in the femoral veins after ultrasound-guided puncture according to institutional standard. If the patient is randomised to the SDD group prior to the procedure, the femoral access will be closed with a closure system. Ablation technique, number of access points and procedural details will be performed according to institutional standard. Patients may be enrolled regardless of the energy source used for ablation. The minimum procedural endpoint is PVI. Ablation strategies in addition to PVI are at the discretion of the operator. Antiarrhythmic therapy may be administered for a maximum of 2 months (blanking period).
Atrial Fibrillation with femoral closure using figure-of-eight stitch
The ablation procedure will be performed under deep sedation/general anaesthesia as standard of care. Vital signs will be monitored. For patients on oral anticoagulation, the procedure will be performed according to the latest guidelines. For catheter access, sheaths will be placed in the femoral veins after ultrasound-guided puncture according to institutional standard. If the patient is randomised to the ONS group prior to the procedure, the femoral access will be closed with a figure-of-eight suture. The ablation technique, number of access points and procedural details will be performed according to institutional standard. Patients may be enrolled regardless of the energy source used for ablation. The minimum procedural endpoint is PVI. Ablation strategies in addition to PVI are at the discretion of the operator. Antiarrhythmic therapy may be administered for a maximum of 2 months (blanking period).
Locations (1)
Klinik für Rhythmologie
Lübeck, Schleswig-Holstein, Germany