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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04880265
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 103.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Cardiac Surgery	Device: BraveHeart wearable life sensors

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
• Actual Study Start Date: Sep 14, 2021
• Anticipated Primary Completion Date: May 1, 2026
• Anticipated Study Completion Date: May 1, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Atrial Fibrillation [Up to 30 days after discharge from the hospital]

   Atrial Fibrillation

Secondary Outcome Measures

1. Other arrhythmias [Up to 30 days after discharge from the hospital]

   Other arrhythmias

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jochen Daniel Muehlschlegel, MD, Associate Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT04880265
• Other Study ID Numbers: 2021P000356
• First Posted: May 10, 2021
• Last Update Posted: Sep 20, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Jochen Daniel Muehlschlegel, MD, Associate Professor, Brigham and Women's Hospital: Wearable Device
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Sep 20, 2021