NCT05563142Completed
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
Source: ClinicalTrials.gov · Last updated 1 Jul 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 125 (actual)
- First submitted
- 27 Sept 2022
- Start date
- 22 Nov 2022
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- University of Luebeck
- Diseases
- Atrial fibrillation
- NCT number
- NCT05563142
What you commit to
- Study type: Interventional
- Participants enrolled: 125
- From 22 Nov 2022 to the primary completion date, 1 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Intraprocedural bleeding or thrombotic complications
Lab values
- Platelet count \< 100,000 cells/mm3
Other
- 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
- Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herz- und Diabeteszentrum Nordrhein-Westfalen Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Unknown status |
| Klinik für Innere Medizin III Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Klinik für Rhythmologie Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.