Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT04880265

Conditions

Atrial Fibrillation

Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Vivalink wearable life sensors

Study Details

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.

Conditions

Atrial Fibrillation

Cardiac Surgery

Study ID

NCT04880265

Start date

Sep 14, 2021

Status verified date

Jun, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients undergoing cardiac surgery

Interventions

Vivalink wearable life sensors

Collection of EKG data

Primary outcome measure

  • Atrial Fibrillation [ Time Frame: Up to 30 days after discharge from the hospital ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jochen D Muehlschlegel, MD, MMSc

617-732-7330jmuehlschlegel@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Wearable Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-30.