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

NCT04880265 | Recruiting FDA Device

• 1 other identifier: 2021P000356
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Wearable Device

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation

  Atrial Fibrillation

  Up to 30 days after discharge from the hospital

Secondary Outcomes (1)

• Other arrhythmias

  Up to 30 days after discharge from the hospital

Study Arms (1)

Patients undergoing cardiac surgery

Device: Vivalink wearable life sensors

Interventions

Vivalink wearable life sensors DEVICE

Collection of EKG data

Patients undergoing cardiac surgery

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing cardiac surgery

You may qualify if:

• Elective open heart surgery
• Age \> 20 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jakob Wollborn, MD MPH

CONTACT

6175258156; jwollborn@bwh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: May 10, 2021
• Study Start: September 14, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)