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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04880265
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Vivalink wearable life sensors — DEVICE
    Collection of EKG data

Study Details

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.

Key Dates

Start date
Sep 14, 2021
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
May 31, 2030

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Patients undergoing cardiac surgery

Primary Outcome Measure

Atrial Fibrillation [ Time Frame: Up to 30 days after discharge from the hospital ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Jochen D Muehlschlegel, MD, MMSc
[email protected]
617-732-7330
Jochen D Muehlschlegel, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Brigham and Women's Hospital· Boston, MA

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