Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

Overview

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 Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 24, 2023

Arms, Groups and Cohorts

  • Patients receiving ICD devices

Clinical Trial Outcome Measures

Primary Measures

  • Successful Implantation
    • Time Frame: Two-week follow-up assessment
    • Patient undergoes surgery for ICD device implantation

Participating in This Clinical Trial

Inclusion Criteria

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

  • N/A

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • QuesGen Systems Inc
  • Collaborator
    • Cardio Surgical Partners
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Michael Jarrett, MBA, 415-608-3570, mike.jarrett@quesgen.com

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