Perclose Multi-Access Duplex Ultrasound (DUS) Study

Arrhythmia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904809
• Other study ID #: ABT-CIP-10410
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 27, 2022

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Device:
• Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	St. Luke's Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 24 hours of procedure.
Primary	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.	Within 24 hours of procedure.