NCT07270848Not yet recruitingPhase 4
Dronedarone Rhythm Intervention for Early Atrial Fibrillation
A Multicenter Prospective Study on the Efficacy, Safety, and Quality of Life Improvements of Dronedarone for Early Rhythm Control in Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to compare two commonly used types of medicine for treating atrial fibrillation (also called AF), a condition that causes an irregular heart rhythm. This study is for adults who have been diagnosed with AF within the past year. Researchers want to find out which medicine is more effective, safer, and provides a better quality of life for patients needing to control their heart rhythm. Participants who agree to join the study will be randomly assigned (like flipping a coin) to one of two groups: Group 1: Will receive the medicine Dronedarone. Group 2: Will receive a standard medicine from the 'Class Ic' group (such as flecainide or propafenone). The study will follow participants for at least 12 months. Researchers will compare how well each medicine works to prevent AF from coming back. They will also carefully track any side effects and changes in participants' quality of life during the study.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1898 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Inha University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07270848
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1898
- From 1 Jan 2026 to the primary completion date, Jun 2028
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of failure with prior antiarrhythmic drug therapy.
- Known contraindications to dronedarone or Class Ic antiarrhythmic drugs.
- Participation in another clinical trial within 3 months prior to randomization.
Other illness
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.
Lab values
- Confirmed severe structural heart disease (e.g., heart failure with reduced ejection fraction \[LVEF \<= 40%\], moderate or severe mitral stenosis, mechanical heart valve replacement, or dilated cardiomyopathy).
- Severe renal impairment (eGFR \< 30 mL/min/1.73m\^2 or on dialysis) or severe hepatic impairment (Child-Pugh class B or higher) that restricts the use of antiarrhythmic drugs.
Other
- Diagnosis of permanent atrial fibrillation.
- Participants who do not agree to refrain from participating in another clinical trial within 14 days after their participation in this study ends.
- Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use effective contraception during the study.
Who the study is looking for
- Participants who have voluntarily provided written informed consent to participate.
- Adults aged 19 years or older.
- Life expectancy of at least 1 year.
- Diagnosis of atrial fibrillation within the past 1 year.
- Participants with an indication for antiarrhythmic drug therapy (Dronedarone or Class Ic agents).
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan | South Korea | Unknown status |
| Soonchunhyang University Bucheon Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Soonchunhyang University Cheonan Hospital Coordinator of this site? Confirm its status | Cheonan | South Korea | Unknown status |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| MyongJi Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| NHIS Ilsan Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Hanyang University Guri Hospital Coordinator of this site? Confirm its status | Guri-si | South Korea | Unknown status |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Unknown status |
| Sejong Chungnam National University Hospital Coordinator of this site? Confirm its status | Sejong | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
Related publications
- Dronedarone vs class Ic agents for early AF: Protocol for the DRIVE-AF randomized clinical trial.Heart Rhythm O2 · 2026 · PMID 42774368
This page is information, not medical advice. Discuss any trial with your doctor.