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

University of Luebeck125 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Atrial Fibrillation

Interventions

deploying vascular closure device versus manual compressionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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.

Time frame: 6 hours

Secondary Outcomes

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 frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 hours

Incidence of major adverse events

Incidence of major adverse events within 30 days after the procedure

Data from ClinicalTrials.gov

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