Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

Recruiting

• Conditions: Arrhythmia

• Registration Number: NCT03604133
• Lead Sponsor: QuesGen Systems Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-24
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22
• Primary Completion: 2023-08-24
• Study Completion: 2028-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful Implantation	Two-week follow-up assessment	Patient undergoes surgery for ICD device implantation

Trial Locations

Locations (1)

Cardio Surgical Partners, LLC; 🇺🇸 Lehi, Utah, United States