Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation

Atrial Fibrillation Clinical Trial

— Style-AF  

Official title:

Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563142
• Other study ID #: Style-AF
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• deploying vascular closure device versus manual compression
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen	Nordrhein-Westfalen
Germany	Klinik für Innere Medizin III	Kiel	Schleswig-Holstein
Germany	Herzzentrum Leipzig	Leipzig	Sachsen
Germany	Klinik für Rhythmologie	Luebeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 hours
Secondary	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	6 hours
Secondary	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	6 hours
Secondary	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	3 days
Secondary	time to discharge	elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution	3 days
Secondary	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	6 hours
Secondary	Incidence of major adverse events	Incidence of major adverse events within 30 days after the procedure	30 days
Secondary	Incidence of minor adverse events	Incidence of minor adverse events within 30 days after the procedure	30 days
Secondary	Time to final hemostasis	Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications	3 days