Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
NCT ID: NCT05563142
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
125 participants
INTERVENTIONAL
2022-11-22
2024-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group Perclose ProStyle closure
50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis
deploying vascular closure device versus manual compression
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Group manual compression
50 patients treated with manual compression and one figure of eight suture
deploying vascular closure device versus manual compression
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Interventions
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deploying vascular closure device versus manual compression
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Luebeck
OTHER
Responsible Party
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Prof. Roland Richard Tilz
Clinical Professor, Head of Rhythmology
Locations
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Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany
Klinik für Innere Medizin III
Kiel, Schleswig-Holstein, Germany
Klinik für Rhythmologie
Lübeck, Schleswig-Holstein, Germany
Countries
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Other Identifiers
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Style-AF
Identifier Type: -
Identifier Source: org_study_id
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