Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Background and Significance: In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown. Specific Aims of Research Project: 1. To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center. 2. To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models.
Conditions:
🦠 Atrial Fibrillation 🦠 Cardiac Surgery
🗓️ Study Start (Actual) 14 September 2021
🗓️ Primary Completion (Estimated) May 2026
✅ Study Completion (Estimated) May 2030
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Elective open heart surgery
    • * Age \> 20 years

    Exclusion Criteria:

    • * Refusal to participate (patient or health care proxy)
    • * Participation in other pharmacological trials
    • * Lack of data or poor data quality which cannot be analyzed for any heart rhythm in 80% of the postoperative study period.
Ages Eligible for Study: 20 Years to 90 Years (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 6 April 2021
  • First Submitted that Met QC Criteria 7 May 2021
  • First Posted 10 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 February 2023
  • Last Update Posted 8 February 2023
  • Last Verified February 2023