5563142
Last Update Posted: 2024-07-01
Recruiting has ended
All Genders accepted | 18 Years + |
125 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
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.
Eligibility
Relevant conditions:
Atrial Fibrillation
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov