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

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT05563142
• Lead Sponsor: University of Luebeck

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.

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-03
• Study Start: 2022-11-22
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Incidence of major adverse events	30 days	Incidence of major adverse events within 30 days after the procedure
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
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
Incidence of minor adverse events	30 days	Incidence of minor adverse events within 30 days after the procedure
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
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

Trial Locations

Locations (3)

Herz- und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Nordrhein-Westfalen, Germany

Klinik für Innere Medizin III; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Klinik für Rhythmologie; 🇩🇪 Luebeck, Schleswig-Holstein, Germany