Characterization and Prediction of Atrial Fibrillation-caused Adverse Events After Hospital Discharge for Cardiac Surgery

Recruiting

• Conditions: Atrial Fibrillation; Death; Stroke, Acute
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT03466125
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The purpose of the research is to identify the frequency and severity of adverse events related to atrial fibrillation that occur after discharge from hospital where the patient underwent cardiac surgery.

The Specific Aims of the proposed study are to:

1. Identify the predictors of postoperative atrial fibrillation after discharge from hospital.

2. Identify the frequency of readmission to hospital, or other resource use such as Emergency Department or outpatient visit, for the treatment or prophylaxis of postoperative AF and consequent stroke or bleeding outcomes.

3. Identify the risks for stroke, death and other morbidity in patients after cardiac surgery and the effect of postoperative AF upon subsequent stroke or bleeding outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

• Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

Exclusion Criteria

• surgical procedures that do not include coronary artery bypass graft surgery, aortic valve surgery or mitral valve surgery;
• surgical procedures that include MAZE surgery, or pulmonary vein isolation, ventricular assist device, heart transplantation, congenital heart surgery, bacterial endocarditis, cardiac trauma, cardiac tumor, ventricular septal defect repair, left ventricular aneurysm repair, pulmonary thromboendarterectomy, sub-aortic stenosis resection or surgical ventricular restoration;
• surgical procedures on patients that have undergone MAZE surgery, AF ablation procedures, pulmonary vein isolation or left atrial appendage resection or ablation (such as Watchman devices).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients who underwent cardiac surgery in Massachusetts	Cardiac surgery	No interventions. A retrospective cohort study of patients who underwent cardiac surgery in Massachusetts in calendar years 2012 - 2016.

Primary Outcome Measures

Name	Time	Method
Acute ischemic stroke	Up to six years after surgery	Acute ischemic stroke
Recurrent atrial fibrillation	Up to six years after surgery	Recurrent atrial fibrillation
Mortality	Up to six years after surgery	Mortality

Trial Locations

Locations (1)

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