Perclose Multi-Access Duplex Ultrasound (DUS) Study

Abbott Medical Devices36 enrolled

Overview

The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arrhythmia

Interventions

Perclose ProGlide SMC System and/or Perclose ProStyle SMCR SystemDEVICE

The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein * All the access sites are planned to be treated with Perclose SMC * Written informed consent is obtained prior to the procedure Exclusion Criteria: * Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure * Prior ipsilateral deep vein thrombosis within 6 months * International Normalization Ratio \>3.5 for patients on warfarin * Subject who is not able to ambulate pre-procedure * Women who are pregnant (based on site standard pre-procedure pregnancy test) * Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months

Locations (2)

Emory University Hospital

Atlanta, Georgia, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Number of Subjects With Major Vascular Complications by DUS Detection at Discharge

Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.

Time frame: Within 24 hours of procedure.

Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge

Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.

Time frame: Within 24 hours of procedure.

Data from ClinicalTrials.gov

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