NCT04880265 Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
| NCT ID | NCT04880265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-09-14 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-09-14 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04880265 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 90 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04880265 currently recruiting?
Yes, NCT04880265 is actively recruiting participants. Contact the research team at jwollborn@bwh.harvard.edu for enrollment information.
Where is the NCT04880265 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04880265 clinical trial?
NCT04880265 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 150 participants.
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