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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03466125
Other study ID # 2017P002261
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 2024

Study information

Verified date February 2023
Source Brigham and Women's Hospital
Contact Jochen D Muehlschlegel, MD, MMSc
Phone 617-732-7330
Email jmuehlschlegel@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiac surgery
Retrospective cohort study

Locations

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

Sponsors (10)

Lead Sponsor Collaborator
Brigham and Women's Hospital Baystate Medical Center, Beth Israel Deaconess Medical Center, Cape Cod Hospital, Massachusetts General Hospital, Memorial University Medical Center, Mount Auburn Hospital, SouthCoast Medical Group, St. Elizabeth's Medical Center, Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrent atrial fibrillation Recurrent atrial fibrillation Up to six years after surgery
Primary Acute ischemic stroke Acute ischemic stroke Up to six years after surgery
Primary Mortality Mortality Up to six years after surgery
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