NCT03604133
Recruiting
Not Applicable
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
ConditionsArrhythmia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmia
- Sponsor
- QuesGen Systems Inc
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Successful Implantation
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Successful Implantation
Time Frame: Two-week follow-up assessment
Patient undergoes surgery for ICD device implantation
Study Sites (1)
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