Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation (Style-AF)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: deploying vascular closure device versus manual compression

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Not yet recruiting
      • Herz- und Diabeteszentrum Nordrhein-Westfalen
      • Contact: Phillip Sommer, Prof. Dr. med.; Phone Number: 1327 +49573197; Email: psommer@hdz-nrw.de
  • Sachsen
    • Leipzig, Sachsen, Germany, 04289
      • Not yet recruiting
      • Herzzentrum Leipzig
      • Contact: Gerhard Hindricks, Prof. Dr. med.; Phone Number: +49341865; Email: rhythmo.herzzentrum@helios-gesundheit.de
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Not yet recruiting
      • Klinik fur Innere Medizin III
      • Contact: Evgeny Lyan, Dr. med.; Phone Number: 22810 +49431500; Email: evgeny.lyan@uksh.de
    • Luebeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Klinik für Rhythmologie
      • Contact: Roland R Tilz, Prof. Dr.med; Phone Number: 44533 0049451500; Email: roland.tilz@uksh.de
      • Contact: Claudia Breithaupt; Phone Number: 44672 0049451500; Email: claudia.breithaupt@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Perclose ProStyle closure; 50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis	Procedure: deploying vascular closure device versus manual compression; patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Active Comparator: Group 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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Incidence of major adverse events	Incidence of major adverse events within 30 days after the procedure	30 days
Incidence of minor adverse events	Incidence of minor adverse events within 30 days after the procedure	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	3 days

Collaborators and Investigators

• Sponsor: University of Luebeck

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Anticipated): October 6, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Style-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No