NCT03604133RecruitingNot Applicable
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- QuesGen Systems Inc
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Successful Implantation
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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