Registry for outcomes of implantable cardioverter-defibrillators in outpatient settings
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
This study looks at the safety and costs of getting implantable cardioverter-defibrillators in outpatient centers to see how well the process works for patients and doctors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | QuesGen Systems Inc Academic / other |
| Locations | 1 site (Lehi, Utah) |
| Trial ID | NCT03604133 on ClinicalTrials.gov |
What this trial studies
This registry aims to evaluate the incidence of serious complications and adverse events associated with the implantation of cardioverter-defibrillators in ambulatory surgical centers. It will also assess the cost and time efficiency for both physicians and patients involved in the process. Data will be collected at screening, during the implant procedure, and two weeks post-implant during a wound check. The study focuses on gathering multi-center data to provide insights into the safety and efficiency of these devices.
Who should consider this trial
Good fit: Ideal candidates are patients recommended by their physicians to receive an implantable cardioverter-defibrillator in an ambulatory surgical center.
Not a fit: Patients who do not have a physician recommendation for the implant will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance patient safety and improve the overall efficiency of implantable cardioverter-defibrillator procedures.
How similar studies have performed: Other studies have shown success in evaluating outcomes and efficiencies in similar settings, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC) Exclusion Criteria: * N/A
Where this trial is running
Lehi, Utah
- Cardio Surgical Partners, LLC — Lehi, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Michael Jarrett, MBA
- Email: mike.jarrett@quesgen.com
- Phone: 415-608-3570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.