N/A
N=36
Perclose Multi-Access Duplex Ultrasound (DUS) Study
Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT04904809 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Jul 2023
Primary outcome: Primary: Number of Subjects With Major Vascular Complications by DUS Detection at Discharge — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Major Vascular Complications by DUS Detection at Discharge |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge |
0; 3; 1; 0; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04904809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.