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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
deploying vascular closure device versus manual compression
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herz- und Diabeteszentrum Nordrhein-Westfalen
  • Herzzentrum Leipzig
  • Klinik für Innere Medizin III
  • Klinik für RhythmologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Perclose ProStyle closure

Group manual compression

Arm Description

50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis

50 patients treated with manual compression and one figure of eight suture

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
time to discharge
elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution
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
Incidence of major adverse events
Incidence of major adverse events within 30 days after the procedure
Incidence of minor adverse events
Incidence of minor adverse events within 30 days after the procedure
Time to final hemostasis
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications

Full Information

First Posted
September 27, 2022
Last Updated
November 22, 2022
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT05563142
Brief Title
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
Acronym
Style-AF
Official Title
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
October 6, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Perclose ProStyle closure
Arm Type
Experimental
Arm Description
50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis
Arm Title
Group manual compression
Arm Type
Active Comparator
Arm Description
50 patients treated with manual compression and one figure of eight suture
Intervention Type
Procedure
Intervention Name(s)
deploying vascular closure device versus manual compression
Intervention Description
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Primary Outcome Measure Information:
Title
Time to ambulation
Description
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.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
total post procedure time
Description
elapsed time between removal of the last procedural device for the index procedure and when the patient was able to successfully ambulate
Time Frame
6 hours
Title
time to hemostasis
Description
elapsed time between removal of the closure device or the sheath and first observed and confirmed venous hemostasis, for each access site
Time Frame
6 hours
Title
time to discharge eligibility
Description
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
Time Frame
3 days
Title
time to discharge
Description
elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution
Time Frame
3 days
Title
time to closure eligibility
Description
elapsed time between removal of the last procedural device for the index procedure and removal of the first closure device or first sheath
Time Frame
6 hours
Title
Incidence of major adverse events
Description
Incidence of major adverse events within 30 days after the procedure
Time Frame
30 days
Title
Incidence of minor adverse events
Description
Incidence of minor adverse events within 30 days after the procedure
Time Frame
30 days
Title
Time to final hemostasis
Description
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Sommer, Prof. Dr. med.
Phone
+49573197
Ext
1327
Email
psommer@hdz-nrw.de
Facility Name
Herzzentrum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Hindricks, Prof. Dr. med.
Phone
+49341865
Ext
0
Email
rhythmo.herzzentrum@helios-gesundheit.de
Facility Name
Klinik für Innere Medizin III
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Lyan, Dr. med.
Phone
+49431500
Ext
22810
Email
evgeny.lyan@uksh.de
Facility Name
Klinik für Rhythmologie
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland R Tilz, Prof. Dr.med
Phone
0049451500
Ext
44533
Email
roland.tilz@uksh.de
First Name & Middle Initial & Last Name & Degree
Claudia Breithaupt
Phone
0049451500
Ext
44672
Email
claudia.breithaupt@uksh.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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