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N/A Completed N=36 Treatment

Perclose Multi-Access Duplex Ultrasound (DUS) Study

Arrhythmias
Source: ClinicalTrials.gov NCT04904809 ↗
Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Jul 2023
Primary outcomePrimary: Number of Subjects With Major Vascular Complications by DUS Detection at Discharge — 0; 0; 0; 0 Participants

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.

Outcome Measures

OutcomeResultp-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 —

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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