CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Perclose ProGlide SMC System and/or Perclose ProStyle SMCR Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04904809
NCT04904809N/ACompleted

Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure (SMC) System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System in Managing Multiple Venous Access Sites (Evaluation by DUS)

Abbott Medical Devices·interventional·Posted May 27, 2021·Updated Jul 20, 2023

In Brief

A clinical study evaluating Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System for Arrhythmia. Completed, enrolled 36 participants across 2 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArrhythmia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 27, 2021
Enrollment StartSep 1, 2021
Primary CompletionMay 27, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.1 years ago

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.