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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Cardiac Surgery
• Intervention / Treatment: Device: BraveHeart wearable life sensors

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jochen D Muehlschlegel, MD MMSc MBA; Phone Number: 6175258156; Email: jmuehlschlegel@bwh.harvard.edu
• Study Contact Backup: Name: Jakob Wollborn, MD; Phone Number: 6177327330; Email: jwollborn@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Jochen D Muehlschlegel, MD, MMSc; Phone Number: 617-732-7330; Email: jmuehlschlegel@bwh.harvard.edu
      • Sub-Investigator: Jochen D Muehlschlegel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing cardiac surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing cardiac surgery	Device: BraveHeart wearable life sensors; Collection of EKG data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation	Atrial Fibrillation	Up to 30 days after discharge from the hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other arrhythmias	Other arrhythmias	Up to 30 days after discharge from the hospital

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2021
• Primary Completion (ANTICIPATED): May 1, 2026
• Study Completion (ANTICIPATED): May 1, 2030

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (ACTUAL): May 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Wearable Device
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2021P000356

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes