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NCT04704050 · ClinicalTrials.gov registry record · Phase 4

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence

A Phase 4 study, sponsored by Tulane University School of Medicine.

Terminated
Registry status
Phase 4
Development phase
22
Enrollment target

NCT04704050: Clinical Trial Phase 4 study, sponsored by Tulane University School of Medicine.

NCT04704050 is a Phase 4 study that was terminated before completion, run by Tulane University School of Medicine. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04704050, a Phase 4 study, was terminated before completion, sponsored by Tulane University School of Medicine.

TERMINATED
Registry status
Phase 4
Development phase
22 participants
Enrollment target

Study 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.

Primary Outcome

Investigators monitored subjects upon discharge, 24-48 hours after AF ablation. This was recorded by either the occurrence of a single positive atrial arrhythmias (AA) ECG reading on a 12-lead ECG, Holter monitor, obtained on the daily event strips from the Preventice monitoring device, or 30-day monitoring patch.

Interventions

  • DRUG Placebo
  • DRUG dronedarone 400 mg Oral Tablet

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2021-05-15
Est. Completion 2022-12-20
Phase Phase 4

Why NCT04704050 stopped before completion

NCT04704050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04704050 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04704050 about?

NCT04704050 is a clinical study titled "Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence". 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...

What is the current status of trial NCT04704050?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2021-05-15. Estimated completion is 2022-12-20.

What interventions are being tested in trial NCT04704050?

The interventions under investigation include: Placebo (DRUG), dronedarone 400 mg Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT04704050?

This trial is sponsored by Tulane University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04704050's enrollment target sits among peer trials

22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04704050, the US trial registry maintained by the National Library of Medicine. NCT04704050 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.