Observational Study of Implantable Cardioverter-Defibrillators in Ambulatory Surgical Centers

This is an observational study looking at the outcomes of patients who receive an implantable cardioverter-defibrillator (ICD) in an Ambulatory Surgical Center (ASC). An ICD is a small device placed in your chest or abdomen that helps regulate your heartbeat if you have an arrhythmia (irregular heartbeat). This study aims to understand how often serious problems or side effects occur with these devices, and to see if having the procedure in an ASC is efficient for both patients and doctors in terms of cost and time. You may be able to join if your doctor recommends you receive an ICD in an ASC. The study will consider the implantation successful if there are no serious complications or adverse events at a two-week follow-up.

Study design
This is an observational study, meaning researchers will collect information about patients who are already receiving care, rather than assigning treatments. It aims to enroll 500 participants.
What's involved
You would have data collected at the time of screening, during the implant procedure, and at a wound check two weeks after the implant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two weeks after the implant for a wound check.

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NCT03604133

Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

Recruiting
Not specifiedAll AgesObservational
QuesGen Systems Inc
~500 participants
Updated 2021-01-22 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful Implantation
Measured over Two-week follow-up assessment
Arrhythmia
1 sites across 1 states
Utah1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)

Exclusion

N/A
  • Successful ImplantationTwo-week follow-up assessment

    Patient undergoes surgery for ICD device implantation