Perclose Multi-Access Duplex Ultrasound (DUS) Study
- Conditions
- Arrhythmia
- Interventions
- Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
- Registration Number
- NCT04904809
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Registered Patients Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System 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.
- Primary Outcome Measures
Name Time Method Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge 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 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States