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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-90
SponsorBrigham and Women's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Elective open heart surgery

Age > 20 years

Disqualifiers

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.

Trial population

patients undergoing cardiac surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Vivalink wearable life sensors

    Device

    Collection of EKG data

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients undergoing cardiac surgery1 intervention

Trial outcomes

Primary outcomes

1

Atrial Fibrillation

Atrial Fibrillation

Time frame
Up to 30 days after discharge from the hospital

Secondary outcomes

1

Other arrhythmias

Other arrhythmias

Time frame
Up to 30 days after discharge from the hospital

Other outcomes

Sponsors and contacts

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