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Antiarrhythmic Agent

Treatment Group for Atrial Fibrillation (EDORA Trial)

Phase 4
Waitlist Available
Led By Nassir F Marrouche, MD
Research Sponsored by Tulane University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

EDORA Trial Summary

This trial will test whether dronedarone prevents atrial fibrillation recurrence and atrial fibrosis progression in patients who have undergone cardiac ablation.

Eligible Conditions
  • Atrial Fibrillation

EDORA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Atrial Fibrillation
Progression of Atrial Fibrosis
Secondary outcome measures
AF Burden (Online questionnaire form)
Antiarrhythmic Initiation or change
Atrial Fibrillation Burden
+5 more
Other outcome measures
Hospitalization
Mortality
Stroke/ Transient Ischemic Attacks (TIA)

EDORA Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control1 Intervention
Dronedarone 400 mg orally, twice per day (BID)
Group II: Control GroupPlacebo Group1 Intervention
Placebo tablet orally, twice per day (BID)

Find a Location

Who is running the clinical trial?

MckessonUNKNOWN
Tulane University School of MedicineLead Sponsor
33 Previous Clinical Trials
17,462 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
1,143 Patients Enrolled for Atrial Fibrillation
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,958 Total Patients Enrolled
34 Trials studying Atrial Fibrillation
146,633 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~6 spots leftby Apr 2025