Can early rhythm control save hearts in AF patients with leaky valves?
NCT ID NCT07607093
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether starting rhythm control early—using drugs or procedures like ablation—can improve outcomes for people with both atrial fibrillation and tricuspid regurgitation (a leaky heart valve). About 5,800 participants will be randomly assigned to early rhythm control or usual care. The goal is to see if early treatment reduces the chance of heart-related death, heart failure, stroke, or needing valve surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-arrhythmic drugs (flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone), DC cardioversion, or catheter ablation
- What this could lead to
- If successful, this could show that early rhythm control reduces the risk of heart-related death, heart failure, stroke, or need for tricuspid valve surgery in these patients.
- What could go wrong
- This is a large but still ongoing study, and the benefits of early rhythm control in this specific group are unproven. The drugs and procedures carry risks like side effects or complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 5,800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The investigator emulated a sequential target trial comparing early rhythm control with usual care among patients with atrial fibrillation and tricuspid regurgitation, using data from the Korean National Health Insurance Service (K-NHIS) claims database. The K-NHIS database represents the entire population of Korea. The K-NHIS database covers the total population of Korea. The NHIS database includes information on all individuals in Korea, such as demographics, diagnosis codes based on the International Classification of Diseases, 10th Revision (ICD-10), procedures, prescriptions (coded by ATC codes), utilization of healthcare services, and mortality linked to national statistics. The investigator further linked these data with the National Health Screening Program, which provides biennial standardized health examination results, including laboratory measurements such as serum creatinine and hemoglobin, using anonymized individual identifiers.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with concomitant atrial fibrillation and tricuspid regurgitation. Exclusion Criteria: * Patients with a history of valvular surgery * Patients with congenital heart disease * Patients with primary pulmonary hypertension * Patients with CIED implantation prior to the diagnosis of tricuspid regurgitation * Patients diagnosed with TR only after the initiation of rhythm control therapy for AF
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Samsung Medical Center
RECRUITINGSeoul, Seoul, 06351, South Korea
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