TerminatedPhase 4

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence

Stopped: Sponsor withdrew funding

United States22 participantsStarted 2021-05-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. are pregnant or breast-feeding or plan to become pregnant during the study period or,
✕. are not surgically sterile or,
✕. are of childbearing potential and not practising two acceptable methods of birth control or,
✕. do not plan to continue practising two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone, or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly).

What they're measuring

Post-ablation Atrial Fibrillation Recurrence

Timeframe: 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.

Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation

Timeframe: 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.

Trial details

NCT IDNCT04704050

SponsorTulane University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-20

Results submitted2023-12-20

View on ClinicalTrials.gov More Atrial Fibrillation trials