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Recruiting

NCT Number: NCT04880265

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.

Recruiting

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Jochen D Muehlschlegel, MD

SUB_INVESTIGATOR

Jochen D Muehlschlegel, MD, MMSc

CONTACT

[email protected]

617-732-7330

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vivalink wearable life sensors

Device

Collection of EKG data

Primary outcomes

  1. Atrial Fibrillation

    Time frame: Up to 30 days after discharge from the hospital

    Atrial Fibrillation

Secondary outcomes

  1. Other arrhythmias

    Time frame: Up to 30 days after discharge from the hospital

    Other arrhythmias

Study contacts

Contact information is provided by the study sponsor or research team.

Jakob Wollborn, MD MPH

CONTACT

[email protected]

6175258156

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
May 10, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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