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The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.
The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most common complication after cardiac surgery. AF is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. Both strategies are commonly used to treat AF. All of the medications that will be used in this study are the standard of care for use in patients experiencing AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Southern California
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States
University of Michigan Health Services
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Einstein Heart Center
The Bronx, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Duke University
Durham, North Carolina, United States
Start Date
May 1, 2014
Primary Completion Date
September 1, 2015
Completion Date
September 1, 2015
Last Updated
March 15, 2019
523
ACTUAL participants
Amiodarone
DRUG
DC-cardioversion
PROCEDURE
Rate Control
DRUG
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
NCT05062239
NCT04657835
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06054360