Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Post Ablation: The EDORA Trial

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04704050

Acronym

EDORA

Enrollment

Registered

2021-01-11

Start date

2021-05-15

Completion date

2022-12-20

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Fibrillation Recurrent

Keywords

Atrial Fibrillation, Atrial Fibrillation Recurrent, Heart Murmur, Dronedarone, Atrial Fibrosis, Atrial Fibrosis Progression, Atrial Fibrosis Regression, Atrial Arrhythmia, Cardiac Arrhythmia, Cardiovascular Events, Multaq

Brief 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.

Detailed description

The purpose of this trial is to determine whether dronedarone is effective in slowing the progression of fibrosis and decreasing atrial fibrillation recurrence in patients who have undergone ablation therapy. Patients with atrial fibrillation (AF) undergoing ablation will be stratified by age and gender (\>65 years and \<65 years, male and female) as well as by type of atrial fibrillation (paroxysmal, persistent, etc.) and then randomized to one of two trial groups. They will either receive dronedarone 400 mg BID (twice daily) (treatment group) or placebo (control group). The control group will be started on placebo, and treating physicians will be advised to limit the initiation of anti-arrhythmic drugs (standard of care, SOC) to necessary cases only, avoiding amiodarone and dronedarone. Each patient will receive a pre-ablation Cardiac Magnetic Resonance imaging (CMR) (SOC) scan, followed by scans at 3 and 12-month post-ablation. Quality of Life (QoL) changes will be evaluated from baseline and at 3 months and 12-months via the Atrial Fibrillation Effect on Quality-Of-Life (AFEQT) online questionnaire form. AF burden (frequency, duration and severity of an AF episode) if present, will be evaluated from baseline and at 3 months and 12-months via the Atrial Fibrillation Severity Scale (AFSS) online questionnaire form. Patients will be followed post-ablation for AF recurrence and burden assessment with a continuous 30-day ECG wearable patch starting at discharge (SOC), then at 3,6,9 and 12 months post-ablation Phone call visits will occur at 6 and 9 months to monitor for medication compliance as well as to assess that devices are working accordingly. Evaluation of adverse events (AE's) as well as whether a patient has reached any trial endpoints will be analyzed at this time. Physicians will be advised to avoid adjustments in drug therapy unless necessary (severely symptomatic patients, patients with heart failure). Severely symptomatic patients will be defined as, patients with non-tolerated palpitations or chest pain, dizziness, syncope, dyspnea, or suddenly reduced ability to exercise. Any initiation or change of an anti-arrhythmic treatment in the treatment or control group will be considered as a secondary endpoint. Patients will continue to be monitored for fibrosis progression and AF burden via CMR scans and ECG wearable devices until the end of the follow-up period. In the case of AF recurrence after ablation, anti-arrhythmic drugs (AAD) initiation or change will be left to the discretion of the treating physician.

Interventions

DRUGdronedarone 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.

DRUGPlacebo

Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients must meet the following criteria to be enrolled in the trial. * Male or female patients aged over 18 years of age. * Patients with paroxysmal or persistent atrial fibrillation who are undergoing ablation of atrial fibrillation, regardless of whether they were receiving an anti-arrhythmic drug (AADs) before enrollment or not.

Exclusion criteria

Patients will be excluded from enrollment if any of the following criteria are present. * Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators \[ICD's\], other devices/implants contraindicated for use of MRI, etc.). * Patients weighing \>300 Ibs. (MRI quality decreases as BMI increases). * Patients with contraindications to dronedarone. (Including patients with decompensated heart failure or class NYHA IV (New York Heart Association Class IV), second or third-degree atrioventricular (AV) block or sick-sinus syndrome \[except when used in conjunction with a functioning pacemaker\]), concomitant use of strong cytochrome P450, family 3, subfamily A (CYP-3A) inhibitors or other Class I or III AADs, drug or herbal products that prolongs the QT interval and may induce Torsades de Pointes. * Liver or lung toxicity related to the previous use of amiodarone, severe hepatic impairment including any stage of cirrhosis and acute liver failure, bradycardia \<50bpm, QTc Bazett interval \>500ms or PR interval \>280ms, or hypersensitivity to the active substance or to any of its excipients. * Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), \<30 mL per minute per 1.73m2 will be excluded from the trial. * Patients with a history of prior left atrial ablation or valvular cardiac surgery (myocardial scarring/fibrosis from prior surgeries may confound data). * Pre-menopausal (last menstruation \<1 year prior to screening) who: 1. are pregnant or breast-feeding or plan to become pregnant during the study period or, 2. are not surgically sterile or, 3. are of childbearing potential and not practising two acceptable methods of birth control or, 4. 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). * Patients who do not have access to the Internet/e-mail. * Patients without daily access to a smart phone-compatible with ECG Check device application and ability to upload ECG tracings for the entire follow-up period. * Patients unable or unwilling to return to the clinic for follow up CMR scans. * Patients with cognitive impairments who are unable to give informed consent.

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.
Cardioversion	1 year	Whether patients in either treatment arm require cardioversion.
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.
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.
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.
Repeat Cardiac Ablation	1 year	Whether patients in either treatment arm require a repeat cardiac ablation.

Other

Measure	Time frame	Description
Mortality	1 year	Records of mortality associated with cardiovascular events.
Stroke/ Transient Ischemic Attacks (TIA)	1 year	Records of stroke or TIA based on cardiac emboli.
Hospitalization	1 year	Records of any cardiac events requiring hospitalization.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Treatment Group Dronedarone 400 mg orally, twice per day (BID) 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.	12
Control Group Placebo tablet orally, twice per day (BID) Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.	10
Total	22

Baseline characteristics

Characteristic	Treatment Group	Control Group	Total
Age, Continuous	66 years	64.50 years	66 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants	9 Participants	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	2 Participants
Region of Enrollment United States	12 participants	10 participants	22 participants
Sex: Female, Male Female	6 Participants	5 Participants	11 Participants
Sex: Female, Male Male	6 Participants	5 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 10
other Total, other adverse events	2 / 12	3 / 10
serious Total, serious adverse events	2 / 12	3 / 10

Outcome results

Primary

Post-ablation Atrial Fibrillation Recurrence

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.

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Group	Post-ablation Atrial Fibrillation Recurrence	2 Participants
Control Group	Post-ablation Atrial Fibrillation Recurrence	1 Participants

Primary

Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation

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.

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Group	Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation	1 Participants
Control Group	Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation	2 Participants

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.

Time frame: 1 year

Arm	Measure	Value (MEAN)	Dispersion
Treatment Group	Atrial Fibrillation Burden	9 Percentage of time	Standard Deviation 4.55
Control Group	Atrial Fibrillation Burden	4.5 Percentage of time	Standard Deviation 5.8

Secondary

Atrial Fibrillation Episodes

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.

Time frame: At baseline, at month 3, at month 12

Arm	Measure	Value (MEAN)	Dispersion
Treatment Group	Atrial Fibrillation Episodes	7.5 Scores on a scale	Standard Deviation 1.73
Control Group	Atrial Fibrillation Episodes	7.8 Scores on a scale	Standard Deviation 2.17

Secondary

Cardioversion

Whether patients in either treatment arm require cardioversion.

Time frame: 1 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Group	Cardioversion	2 Participants
Control Group	Cardioversion	1 Participants

Secondary

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Assessment of adverse events related to treatment given. Evaluated at 3, 12 months visits and during 6 & 9 month phone call visits.

Time frame: Through trial completion, up to 56 weeks.

Arm	Measure	Group	Value (NUMBER)
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Excessive flatulence	0 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Thrombocytopenia	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Hemorrhoids	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Intermittent Nausea	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Prostate hyperplasia	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Fatigue	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Hypertension	0 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Intermittent Headache	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Worsening of Hyperlipidemia	0 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Dyspnea	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Right lung mass	0 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Upset Stomach	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Increased shoulder pain	0 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Elevated creatinine	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Leukocytosis	0 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Right shoulder pain	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Nausea	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Dyspnea on effort	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Diarrhea	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Right rotator cuff tear	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Rash on Chest	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Hypoxemia	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Spinal Stenosis	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Elevated uric acid levels	0 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Urinary incontinence	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Increased Troponin	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Erectile dysfunction	1 Events
Treatment Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Anemia	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Erectile dysfunction	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Anemia	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Fatigue	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Hypoxemia	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Elevated creatinine	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Thrombocytopenia	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Dyspnea	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Dyspnea on effort	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Increased Troponin	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Intermittent Nausea	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Intermittent Headache	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Upset Stomach	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Right shoulder pain	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Right rotator cuff tear	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Elevated uric acid levels	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Excessive flatulence	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Hemorrhoids	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Prostate hyperplasia	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Hypertension	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Worsening of Hyperlipidemia	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Right lung mass	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Increased shoulder pain	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Leukocytosis	1 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Nausea	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Diarrhea	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Rash on Chest	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Spinal Stenosis	0 Events
Control Group	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Urinary incontinence	0 Events

Secondary

Quality of Life (Online Questionnaire Form)

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.

Time frame: At baseline, at month 3, at month 12

Arm	Measure	Value (MEAN)	Dispersion
Treatment Group	Quality of Life (Online Questionnaire Form)	8.8 Scores on a scale	Standard Deviation 1.3
Control Group	Quality of Life (Online Questionnaire Form)	10 Scores on a scale	Standard Deviation 0

Secondary

Repeat Cardiac Ablation

Whether patients in either treatment arm require a repeat cardiac ablation.

Time frame: 1 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Group	Repeat Cardiac Ablation	1 Participants
Control Group	Repeat Cardiac Ablation	0 Participants

Other Pre-specified

Hospitalization

Records of any cardiac events requiring hospitalization.

Time frame: 1 year

Arm	Measure	Group	Value (NUMBER)
Treatment Group	Hospitalization	Hypotension	0 Events
Treatment Group	Hospitalization	GERD	0 Events
Treatment Group	Hospitalization	Anemia	1 Events
Treatment Group	Hospitalization	Peripheral neuropathy	1 Events
Treatment Group	Hospitalization	Left upper extremity swelling	0 Events
Treatment Group	Hospitalization	Increased Troponin	1 Events
Treatment Group	Hospitalization	Chest Pain	0 Events
Treatment Group	Hospitalization	Right lower extremity swelling	0 Events
Treatment Group	Hospitalization	Acute gout flare-up	0 Events
Treatment Group	Hospitalization	Fluid Overload	0 Events
Treatment Group	Hospitalization	Dizziness	0 Events
Treatment Group	Hospitalization	Acute Kidney Injury	0 Events
Treatment Group	Hospitalization	Left lower extremity swelling	0 Events
Treatment Group	Hospitalization	Acute Tubular Necrosis	0 Events
Treatment Group	Hospitalization	Dyspnea	0 Events
Treatment Group	Hospitalization	Hyperkalemia	0 Events
Treatment Group	Hospitalization	Cellulitis	0 Events
Treatment Group	Hospitalization	Hematuria	0 Events
Control Group	Hospitalization	Hypotension	1 Events
Control Group	Hospitalization	Left lower extremity swelling	1 Events
Control Group	Hospitalization	Acute gout flare-up	1 Events
Control Group	Hospitalization	Cellulitis	1 Events
Control Group	Hospitalization	Anemia	0 Events
Control Group	Hospitalization	Chest Pain	1 Events
Control Group	Hospitalization	Dizziness	1 Events
Control Group	Hospitalization	Dyspnea	1 Events
Control Group	Hospitalization	Hematuria	1 Events
Control Group	Hospitalization	GERD	1 Events
Control Group	Hospitalization	Peripheral neuropathy	0 Events
Control Group	Hospitalization	Increased Troponin	0 Events
Control Group	Hospitalization	Right lower extremity swelling	1 Events
Control Group	Hospitalization	Fluid Overload	1 Events
Control Group	Hospitalization	Acute Kidney Injury	1 Events
Control Group	Hospitalization	Acute Tubular Necrosis	1 Events
Control Group	Hospitalization	Hyperkalemia	1 Events
Control Group	Hospitalization	Left upper extremity swelling	1 Events

Other Pre-specified

Mortality

Records of mortality associated with cardiovascular events.

Time frame: 1 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Group	Mortality	0 Participants
Control Group	Mortality	0 Participants

Other Pre-specified

Stroke/ Transient Ischemic Attacks (TIA)

Records of stroke or TIA based on cardiac emboli.

Time frame: 1 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Group	Stroke/ Transient Ischemic Attacks (TIA)	0 Participants
Control Group	Stroke/ Transient Ischemic Attacks (TIA)	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026

Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Post-ablation Atrial Fibrillation Recurrence

Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation

Atrial Fibrillation Burden

Atrial Fibrillation Episodes

Cardioversion

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Quality of Life (Online Questionnaire Form)

Repeat Cardiac Ablation

Hospitalization

Mortality

Stroke/ Transient Ischemic Attacks (TIA)