An interventional study of deploying vascular closure device versus manual compression in Atrial Fibrillation, sponsored by University of Luebeck. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by University of Luebeck · Not applicable, Interventional, and Treatment
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).
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 125 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis
Procedure: deploying vascular closure device versus manual compression
50 patients treated with manual compression and one figure of eight suture
Procedure: deploying vascular closure device versus manual compression
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Time to ambulation
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.
Time frame: 6 hours
total post procedure time
elapsed time between removal of the last procedural device for the index procedure and when the patient was able to successfully ambulate
Time frame: 6 hours
time to hemostasis
elapsed time between removal of the closure device or the sheath and first observed and confirmed venous hemostasis, for each access site
Time frame: 6 hours
time to discharge eligibility
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 frame: 3 days
time to discharge
elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution
Time frame: 3 days
time to closure eligibility
elapsed time between removal of the last procedural device for the index procedure and removal of the first closure device or first sheath
Time frame: 6 hours
Incidence of major adverse events
Incidence of major adverse events within 30 days after the procedure
Time frame: 30 days
Incidence of minor adverse events
Incidence of minor adverse events within 30 days after the procedure
Time frame: 30 days
Time to final hemostasis
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Time frame: 3 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Luebeck