Trial · NCT04704050
Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
NCT04704050, Phase 4, Terminated, Tulane University School of Medicine; results first posted 2025-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence. Trials, record NCT04704050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04704050
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
- NCT number
- NCT04704050
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 22 participants, actual
- Lead sponsor
- Tulane University School of Medicine
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Recurrent
- Interventions
- dronedarone 400 mg Oral Tablet, Placebo
- First posted
- 2021-01-11
- Last updated
- 2025-10-30
- Results first posted
- 2025-10-16
- Limitations and caveats
- Early termination and incomplete data collections for several outcome measures. All data that was collected was added to the results section for this study.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-ablation Atrial Fibrillation Recurrence | 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. | 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. |
| Primary | Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation | 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. | New anti-arrhythmic drug (AAD) initiation for AF recurrence after AF ablation, including initiation of the treatment during the blanking period, or with no available positive ECG reading. |
| Secondary | Atrial Fibrillation Episodes | At baseline, at month 3, at month 12 | Atrial arrhythmia (AA) episodes associated with palpitations, chest pain, dyspnea, dizziness, syncope, or unusual fatigue and weakness were assessed using the Atrial Fibrillation Severity Scale (AFSS) questionnaire. The AFSS is a validated questionnaire designed to measure the burden of atrial arrhythmias, including atrial fibrillation and other irregular heart rhythms. The AA symptom burden score is derived from the AFSS summary score, which averages the frequency, duration, and patient-perceived severity of AA episodes. The AFSS symptom burden score ranges from 3 to 30, with higher scores indicating greater AA burden. Subscale scores (frequency, duration, and severity) are each rated on a scale of 1 to 10 and are averaged to calculate the total burden score. Patients completed the AFSS at baseline, 3 months, and 12 months. Reported data in the results table reflect the mean score at the 12-month time point. |
| Secondary | Repeat Cardiac Ablation | 1 year | Whether patients in either treatment arm require a repeat cardiac ablation. |
| Secondary | Cardioversion | 1 year | Whether patients in either treatment arm require cardioversion. |
| Secondary | Atrial Fibrillation Burden | 1 year | 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. |
| Secondary | Quality of Life (Online Questionnaire Form) | At baseline, at month 3, at month 12 | Quality of life (QoL) was assessed through the Atrial Fibrillation Severity Scale (AFSS), a validated instrument that evaluates the impact of AF across multiple domains, including symptom burden, health care utilization, and overall well-being. The Global Well-being domain of the AFSS is assessed using a single-item question (A4), which measures overall quality of life on a scale from 1 to 10, where higher scores indicate better quality of life. Patients completed the questionnaire at baseline, 3 months, and 12 months. The reported data in the results table reflect the mean score at the 12-month time point. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through trial completion, up to 56 weeks. | Assessment of adverse events related to treatment given. Evaluated at 3, 12 months visits and during 6 \& 9 month phone call visits. |
| Other | Hospitalization | 1 year | Records of any cardiac events requiring hospitalization. |
| Other | Mortality | 1 year | Records of mortality associated with cardiovascular events. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post-ablation Atrial Fibrillation Recurrence | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Atrial Fibrillation Episodes | At baseline, at month 3, at month 12 | Scores on a scale | MEAN | |
| SECONDARY | Repeat Cardiac Ablation | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cardioversion | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Atrial Fibrillation Burden | 1 year | Percentage of time | MEAN | |
| SECONDARY | Quality of Life (Online Questionnaire Form) | At baseline, at month 3, at month 12 | Scores on a scale | MEAN | |
| SECONDARY | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through trial completion, up to 56 weeks. | Events | NUMBER | |
| OTHER_PRE_SPECIFIED | Hospitalization | 1 year | Events | NUMBER | |
| OTHER_PRE_SPECIFIED | Mortality | 1 year | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post-ablation Atrial Fibrillation Recurrence | Treatment Group | 2 | Participants | ||
| Post-ablation Atrial Fibrillation Recurrence | Control Group | 1 | Participants | ||
| Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation | Treatment Group | 1 | Participants | ||
| Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation | Control Group | 2 | Participants | ||
| Atrial Fibrillation Episodes | Treatment Group | 7.5 | Standard Deviation 1.73 | Scores on a scale | |
| Atrial Fibrillation Episodes | Control Group | 7.8 | Standard Deviation 2.17 | Scores on a scale | |
| Repeat Cardiac Ablation | Treatment Group | 1 | Participants | ||
| Repeat Cardiac Ablation | Control Group | 0 | Participants | ||
| Cardioversion | Treatment Group | 2 | Participants | ||
| Cardioversion | Control Group | 1 | Participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group | 12 | |
| Overall Study | STARTED | Control Group | 10 | |
| Overall Study | COMPLETED | Treatment Group | 6 | |
| Overall Study | COMPLETED | Control Group | 7 | |
| Overall Study | NOT COMPLETED | Treatment Group | 6 | |
| Overall Study | NOT COMPLETED | Control Group | 3 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Cardiac disorders | Treatment Group | 0 | 12 | 0 |
| other | Hypertension | Cardiac disorders | Control Group | 1 | 10 | 1 |
| other | Worsening of Hyperlipidemia | Cardiac disorders | Treatment Group | 0 | 12 | 0 |
| other | Worsening of Hyperlipidemia | Cardiac disorders | Control Group | 1 | 10 | 1 |
| other | Dyspnea | Cardiac disorders | Treatment Group | 1 | 12 | 1 |
| other | Dyspnea | Cardiac disorders | Control Group | 0 | 10 | 0 |
| other | Dyspnea on effort | Cardiac disorders | Treatment Group | 1 | 12 | 1 |
| other | Dyspnea on effort | Cardiac disorders | Control Group | 0 | 10 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment Group | 1 | 12 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Control Group | 0 | 10 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group | 0 | 12 |
| Total, all-cause mortality | Control Group | 0 | 10 |
| Total, other adverse events | Treatment Group | 2 | 12 |
| Total, other adverse events | Control Group | 3 | 10 |
| Total, serious adverse events | Treatment Group | 2 | 12 |
| Total, serious adverse events | Control Group | 3 | 10 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Group vs Control Group: Stroke/ Transient Ischemic Attacks (TIA) | Trial comparisons |
| Treatment Group vs Control Group: Repeat Cardiac Ablation | Trial comparisons |
| Treatment Group vs Control Group: Post-ablation Atrial Fibrillation Recurrence | Trial comparisons |
| Treatment Group vs Control Group: Cardioversion | Trial comparisons |
| Treatment Group vs Control Group: Mortality | Trial comparisons |
| Treatment Group vs Control Group: Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation | Trial comparisons |
| Treatment Group vs Control Group: deaths from any cause | Trial comparisons |
| Treatment Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04704050
GET https://conductscience.org/api/trials/v1/NCT04704050/results?page=2