Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
Part of paid clinical trials in Lehi, Utah.
- Sponsor
- QuesGen Systems Inc
- Study ID
- NCT03604133
- Status
- Recruiting
Conditions
- Arrhythmia
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Aug 24, 2017
- Status verified
- Jan 2021
- Primary completion
- Aug 24, 2023
- Completion
- Aug 24, 2028
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: Patients receiving ICD devices
Primary Outcome Measure
Successful Implantation [ Time Frame: Two-week follow-up assessment ]
Central Contacts
- Michael Jarrett, MBA415-608-3570
- Martin Jorgensen, PhD650-777-7617
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cardio Surgical Partners, LLC | Lehi | Utah | 84043 |
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