Cardiac Implantable Electronic Device (CIED) Research Study
The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.
Conditions:
🦠 Arrhythmias, Cardiac 🦠 Bradycardia 🦠 Tachycardia
🗓️ Study Start (Actual) 17 March 2022
🗓️ Primary Completion (Estimated) 23 July 2027
✅ Study Completion (Estimated) 1 May 2028
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Gainesville, Florida, United States
📍 Macon, Georgia, United States
📍 Portland, Oregon, United States
📍 Lancaster, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Charlottesville, Virginia, United States
📍 Falls Church, Virginia, United States
📍 Norfolk, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Subject is at least 18 years of age.
    • 2. Subject is willing and able to provide written informed consent.
    • 3. Subject is willing and able to complete the study procedures and visits for the duration of data collection requirements

    Exclusion Criteria:

    • 1. Subject is unwilling or unable to comply with study procedures as defined in the protocol.
    • 2. Subject with a medical condition that precludes the patient from participation in the opinion of the investigator.
    • 3. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 20 September 2021
  • First Submitted that Met QC Criteria 20 September 2021
  • First Posted 30 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified April 2024