Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- University of Luebeck
- Enrollment
- 125
- Locations
- 3
- Primary Endpoint
- Time to ambulation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).
Detailed Description
The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.
Investigators
Prof. Roland Richard Tilz
Clinical Professor, Head of Rhythmology
University of Luebeck
Eligibility Criteria
Inclusion Criteria
- •Patients age \>18
- •Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites
Exclusion Criteria
- •Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- •Platelet count \< 100,000 cells/mm3
- •BMI \> 45 kg/m2 or \< 20 kg/m2
- •Attempted femoral arterial access or inadvertent arterial puncture
- •Procedural complications that interfered with routine recovery, ambulation, or discharge times
- •Incorrect sheath placement
- •Intraprocedural bleeding or thrombotic complications
- •Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
Outcomes
Primary Outcomes
Time to ambulation
Time Frame: 6 hours
elapsed time between removal of the final closure device or removal of the final sheath and when the patient can stand and walk 20 ft without evidence of venous re-bleeding from the femoral access site.
Secondary Outcomes
- time to hemostasis(6 hours)
- time to discharge eligibility(3 days)
- Incidence of major adverse events(30 days)
- total post procedure time(6 hours)
- time to discharge(3 days)
- Incidence of minor adverse events(30 days)
- time to closure eligibility(6 hours)
- Time to final hemostasis(3 days)