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Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04880265
Enrollment
150
Registered
2021-05-10
Start date
2021-09-14
Completion date
2030-05-01
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Cardiac Surgery

Keywords

Wearable Device

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.

Interventions

DEVICEVivalink wearable life sensors

Collection of EKG data

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Atrial FibrillationUp to 30 days after discharge from the hospitalAtrial Fibrillation

Secondary

MeasureTime frameDescription
Other arrhythmiasUp to 30 days after discharge from the hospitalOther arrhythmias

Countries

United States

Contacts

CONTACTJakob Wollborn, MD MPH
jwollborn@bwh.harvard.edu6175258156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026