Arrhythmia Clinical Trial
— ASC ICD RegOfficial title:
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | August 24, 2028 |
| Est. primary completion date | August 24, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC) Exclusion Criteria: - N/A |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cardio Surgical Partners, LLC | Lehi | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| QuesGen Systems Inc | Cardio Surgical Partners |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful Implantation | Patient undergoes surgery for ICD device implantation | Two-week follow-up assessment |
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