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).
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
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
Parallel
Atrial Fibrillation with femoral closure using closing system
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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).
30 Day vascular access-related adverse events
Primary Safety Endpoint
Time to ambulation
Primary Efficacy Endpoint elapsed time between removal of the final closure device or removal of final sheath and the moment when the patient stood and walked 20 ft without evidence of venous re-bleeding from the femoral access site (time to ambulation; TTA)
Quality of Life assessment - EQ-5D-5L
Secondary Efficacy Endpoint quality of life assessment (QoL) using the EQ-5D-5L questionnaire which contains 5 questions on current well-being and a scale from 0-100 on the personal assessment of the state of current health (from 0 (very poor) to 100 (very good)).
Quality of Life assessment - AFEQT
Secondary Efficacy Endpoint quality of life assessment (QoL) using the AFEQT questionnaire. which contains 20 questions on 7-point Likert scale on current well-being. Finally, a score between 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered) of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered)
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