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

Recruiting

• Conditions: Atrial Fibrillation; Cardiac Surgery
• Interventions: Device: BraveHeart wearable life sensors

• Registration Number: NCT04880265
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-10
• Study Start: 2021-09-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2026-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing cardiac surgery	BraveHeart wearable life sensors	-

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation	Up to 30 days after discharge from the hospital	Atrial Fibrillation

Secondary Outcome Measures

Name	Time	Method
Other arrhythmias	Up to 30 days after discharge from the hospital	Other arrhythmias

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States