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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04704050
Other study ID # 2830294
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 15, 2021
Est. completion date December 20, 2022

Study information

Verified date April 2023
Source Tulane University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients who have undergone cardiac ablation will be randomized and blinded to one of two groups; one group will receive dronedarone while the other group will receive a placebo. The incidence of atrial fibrillation recurrence, as well as atrial fibrosis progression, will be analyzed between the two trial groups.


Description:

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Study Design


Intervention

Drug:
dronedarone 400 mg Oral Tablet
Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV. Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
Placebo
Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States University of Colorado Health Memorial Colorado Springs Colorado
United States Baylor College of Medicine Houston Texas
United States Tulane University School of Medicine New Orleans Louisiana

Sponsors (6)

Lead Sponsor Collaborator
Tulane University School of Medicine Marrek, INC, Mckesson, Preventice, Sanofi, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Other Hospitalization Records of any cardiac events requiring hospitalization. 1 year
Other Mortality Records of mortality associated with cardiovascular events. 1 year
Other Stroke/ Transient Ischemic Attacks (TIA) Records of stroke or TIA based on cardiac emboli. 1 year
Primary Post-ablation Atrial Fibrillation Recurrence Time to first atrial fibrillation recurrence after ablation in both treatment groups. Up to 56 weeks. From date of ablation until the date of first documented Atrial Fibrillation recurrence, whichever came first, assessed up to 56 weeks.
Primary Post-ablation Atrial Fibrillation Recurrence New anti-arrythmic drug (AAD) initiation for atrial fibrillation recurrence after ablation in both treatment groups. Through trial completion, an average of 1 year.
Primary Progression of Atrial Fibrosis To see whether patients in the treatment group have change in atrial fibrosis, visualized on their CMR scans compared to those who were in the placebo group. Comparing baseline CMR scan to 12 month CMR scan.
Secondary Antiarrhythmic Initiation or change Any initiation or change to anti-arrhythmic therapy after ablation to either the treatment or control group. Up to 56 weeks. From the date of ablation until the date of first documented Antiarrhythmic drug initiation/change, whichever came first, assessed up to 56 weeks.
Secondary Atrial Fibrillation Episodes Incidences or symptoms of atrial fibrillation (e.g. palpitations, chest pain, dyspnea, dizziness, syncope, unusual fatigue and weakness). 1 year
Secondary Repeat Cardiac Ablation Whether patients in either treatment arm require a repeat cardiac ablation. 1 year
Secondary Cardioversion Whether patients in either treatment arm require cardioversion. 1 year
Secondary Atrial Fibrillation Burden The percentage of time a patient is in atrial fibrillation during the monitoring period, 24-48 hours and, at 3 months and 12 months post-ablation. Burden will be recorded as a time-weighted average (%) based on data from wearable devices. 1 year
Secondary Quality of Life (Online questionnaire form) This will be assessed through the Atrial Fibrillation Effect on Quality-Of-Life (AFEQT) online questionnaire form at baseline, 3 and 12 month follow up visits. 1 year
Secondary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Assessment of adverse events related to dronedarone. Evaluated at 3, 12 months visits and during 6 & 9 month phone call visits. Through trial completion, up to 56 weeks.
Secondary AF Burden (Online questionnaire form) This will be assessed through the Atrial Fibrillation Severity Scale (AFSS) online questionnaire form at baseline, 3 and 12 month follow up visits. 1 year
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