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Treatment Group for Atrial Fibrillation (EDORA Trial)
EDORA Trial Summary
This trial will test whether dronedarone prevents atrial fibrillation recurrence and atrial fibrosis progression in patients who have undergone cardiac ablation.
- Atrial Fibrillation
EDORA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EDORA Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Is recruitment still open for this research endeavor?
"According to the information hosted on clinicaltrials.gov, no further participants are required for this trial that was initially posted in May 2021 and last updated in November 2022. However, there are 1,952 other studies actively recruiting new enrollees at present."
Is there prior research that has studied the effects of Treatment Group?
"Currently, four independent studies are being conducted on Treatment Group; all of which are in the earlier stages. Geographically speaking, there are 32 medical centres conducting research for this treatment - with a majority based out of New Orleans, Louisiana."
How many participants are taking part in the trial?
"As of now, this trial is not enrolling new participants. Initially posted on May 15th 2021 and last updated on November 21st 2022, it has since been closed for recruitment. However, 1948 studies pertaining to atrial fibrillation are actively seeking patients along with 4 clinical trials targeting the Treatment Group."
In which medical institutions are the results of this trial being collected?
"Emory University in Atlanta, Baylor College of Medicinein Houston, and the University of Colorado Health Memorial in Colorado Springs are among the 4 sites running this trial. Additionally, there is a fourth location recruiting patients for this research."
Has the FDA sanctioned Treatment Group?
"Data collected up to this point suggests that Treatment Group has achieved a level of safety rated 3 out of 3 on the scale, allowing it to move into Phase 4 and receive official approval."
What goals are investigators hoping to accomplish with this clinical investigation?
"The primary metric of success in this trial, according to the sponsor Sanofi, is an evaluation of Atrial Fibrosis progression over a period lasting up to one year. Secondary outcomes include AF Burden (measured by the Atrial fibrillation Severity Scale questionnaire), incidence and symptoms related to atrial fibrilation as well as time-weighted average percentages from wearable devices recorded during 24-48 hour monitoring periods pre and post ablation treatment procedures."
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