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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880265
• Other study ID #: 2021P000356
• Status: Recruiting
• Start date: September 14, 2021
• Est. completion date: May 2030

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: Jochen D Muehlschlegel, MD MMSc MBA
• Phone: 6175258156
• Email: jmuehlschlegel[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2030
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Surgery

Intervention

Device:
• BraveHeart wearable life sensors
Collection of EKG data

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation	Atrial Fibrillation	Up to 30 days after discharge from the hospital
Secondary	Other arrhythmias	Other arrhythmias	Up to 30 days after discharge from the hospital