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

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ClinicalTrials.gov Identifier: NCT05563142
Recruitment Status : Recruiting
First Posted : October 3, 2022
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Roland Richard Tilz, University of Luebeck

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: deploying vascular closure device versus manual compression Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
Actual Study Start Date : November 22, 2022
Estimated Primary Completion Date : October 6, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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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:


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05563142


Locations
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Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen Not yet recruiting
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Contact: Phillip Sommer, Prof. Dr. med.    +49573197 ext 1327    psommer@hdz-nrw.de   
Herzzentrum Leipzig Not yet recruiting
Leipzig, Sachsen, Germany, 04289
Contact: Gerhard Hindricks, Prof. Dr. med.    +49341865 ext 0    rhythmo.herzzentrum@helios-gesundheit.de   
Klinik für Innere Medizin III Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Evgeny Lyan, Dr. med.    +49431500 ext 22810    evgeny.lyan@uksh.de   
Klinik für Rhythmologie Recruiting
Luebeck, Schleswig-Holstein, Germany, 23538
Contact: Roland R Tilz, Prof. Dr.med    0049451500 ext 44533    roland.tilz@uksh.de   
Contact: Claudia Breithaupt    0049451500 ext 44672    claudia.breithaupt@uksh.de   
Sponsors and Collaborators
University of Luebeck
More Information
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Responsible Party: Prof. Roland Richard Tilz, Clinical Professor, Head of Rhythmology, University of Luebeck
ClinicalTrials.gov Identifier: NCT05563142    
Other Study ID Numbers: Style-AF
First Posted: October 3, 2022    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes