Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREdeploying vascular closure device versus manual compression
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Sponsors
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to ambulation | 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
| Measure | Time frame | Description |
|---|---|---|
| time to hemostasis | 6 hours | elapsed time between removal of the closure device or the sheath and first observed and confirmed venous hemostasis, for each access site |
| time to discharge eligibility | 3 days | elapsed time between removal of the final closure device or final sheath and when the patient was eligible for hospital discharge based solely on the assessment of the access site, as determined by the medical team |
| time to discharge | 3 days | elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution |
| total post procedure time | 6 hours | elapsed time between removal of the last procedural device for the index procedure and when the patient was able to successfully ambulate |
| Incidence of major adverse events | 30 days | Incidence of major adverse events within 30 days after the procedure |
| Incidence of minor adverse events | 30 days | Incidence of minor adverse events within 30 days after the procedure |
| Time to final hemostasis | 3 days | Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications |
| time to closure eligibility | 6 hours | elapsed time between removal of the last procedural device for the index procedure and removal of the first closure device or first sheath |
Countries
Germany
Outcome results
None listed