Actively Recruiting
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
Led by QuesGen Systems Inc · Updated on 2021-01-22
500
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
Q
QuesGen Systems Inc
Lead Sponsor
C
Cardio Surgical Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting data through a registry to study the outcomes of implantable cardioverter-defibrillators (ICDs) placed in ambulatory surgical centers for patients with arrhythmia. The main goals are to determine how often serious complications or adverse events occur with both initial and replacement ICD implants and to evaluate the time and cost efficiency for doctors and patients. This registry gathers information at several points: during screening, at the time of implant, and two weeks afterward during a wound check. The study focuses on patients receiving ICD devices in outpatient ambulatory surgical centers, without comparison groups or experimental treatments. Participants will have their implantation success assessed at a two-week follow-up. Data collection includes monitoring for complications and efficiency outcomes. The registry runs from August 2017 until August 2028, and participants will undergo routine clinical evaluations associated with their ICD implantation and follow-up care.
CONDITIONS
Brief Title
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants undergo implantation of the implantable cardioverter-defibrillator (ICD) device in an Ambulatory Surgical Center.
1 visit (in-person)
Duration - 2 weeks
Participants are followed up to assess successful implantation and health status after ICD device placement.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Cardio Surgical Partners, LLC
Lehi, Utah, United States, 84043
Actively Recruiting
Research Team
M
Michael Jarrett, MBA
M
Martin Jorgensen, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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