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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
All Registered Patients
All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System.
Intervention: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System (Device)
Outcomes
Primary Outcomes
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
Time Frame: Within 24 hours of procedure.
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.
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
Time Frame: Within 24 hours of procedure.
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.
Secondary Outcomes
No secondary outcomes reported