Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vivalink wearable life sensors.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Cardiac Surgery. Basic parameters: 20 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Vivalink wearable life sensors
Collection of EKG data
Primary outcome measures
- Atrial Fibrillation [Time frame: Up to 30 days after discharge from the hospital]
Secondary outcome measures (1)
- Other arrhythmias [Time frame: Up to 30 days after discharge from the hospital]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT04880265 · 2021P000356