Clincosm LogoSign in Get a demo

ASC ICD Reg: Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

Sponsor
QuesGen Systems Inc (Other)
Overall Status
Recruiting
CT.gov ID
NCT03604133
Collaborator
Cardio Surgical Partners (Other)
500
Enrollment
1
Location
132
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
    Actual Study Start Date :
    Aug 24, 2017
    Anticipated Primary Completion Date :
    Aug 24, 2023
    Anticipated Study Completion Date :
    Aug 24, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    Patients receiving ICD devices

    Outcome Measures

    Primary Outcome Measures

    1. Successful Implantation [Two-week follow-up assessment]

      Patient undergoes surgery for ICD device implantation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardio Surgical Partners, LLC Lehi Utah United States 84043

    Sponsors and Collaborators

    • QuesGen Systems Inc
    • Cardio Surgical Partners

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    QuesGen Systems Inc
    ClinicalTrials.gov Identifier:
    NCT03604133
    Other Study ID Numbers:
    • 2018-310 Cardiac Registry
    First Posted:
    Jul 27, 2018
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arrhythmias, Cardiac

    Study Results

    No Results Posted as of Jan 22, 2021