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Procedure

All Registered Patients for Arrhythmia

N/A
Waitlist Available
Led By Brett Gidney, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of procedure.
Awards & highlights

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.

Eligible Conditions
  • Arrhythmia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure to 30 days post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure to 30 days post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
Secondary study objectives
All Reported Vascular Complications
Anticoagulant and antiplatelet medications
Device Success rate per access site
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All Registered PatientsExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
2021
N/A
~40

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
647 Previous Clinical Trials
408,498 Total Patients Enrolled
17 Trials studying Arrhythmia
10,398 Patients Enrolled for Arrhythmia
Brett Gidney, MDPrincipal InvestigatorSanta Barbara Cottage Hospital
1 Previous Clinical Trials
234 Total Patients Enrolled
Sanjaya K Gupta, MDPrincipal InvestigatorSt. Luke's Hospital
1 Previous Clinical Trials
532 Total Patients Enrolled
~9 spots leftby Sep 2025
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