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

January 20, 2021 updated by: QuesGen Systems Inc
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Lehi, Utah, United States, 84043
        • Recruiting
        • Cardio Surgical Partners, LLC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals who require ICD to maintain optimal health.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients receiving ICD devices

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QuesGen Systems Inc

Collaborators

Cardio Surgical Partners

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2017

Primary Completion (Anticipated)

August 24, 2023

Study Completion (Anticipated)

August 24, 2028

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-310 Cardiac Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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