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Completed

NCT Number: NCT05563142

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deploying vascular closure device versus manual compression

Procedure

patients will be randomized to either group 1 or group 2 in a 1:1 ratio:

Primary outcomes

  1. Time to ambulation

    Time frame: 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 outcomes

  1. total post procedure time

    Time frame: 6 hours

    elapsed time between removal of the last procedural device for the index procedure and when the patient was able to successfully ambulate

  2. time to hemostasis

    Time frame: 6 hours

    elapsed time between removal of the closure device or the sheath and first observed and confirmed venous hemostasis, for each access site

  3. time to discharge eligibility

    Time frame: 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

  4. time to discharge

    Time frame: 3 days

    elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution

  5. time to closure eligibility

    Time frame: 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

  6. Incidence of major adverse events

    Time frame: 30 days

    Incidence of major adverse events within 30 days after the procedure

  7. Incidence of minor adverse events

    Time frame: 30 days

    Incidence of minor adverse events within 30 days after the procedure

  8. Time to final hemostasis

    Time frame: 3 days

    Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study title

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

Acronym: Style-AF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2022
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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