Heart failure and AF: which procedure works best?
NCT ID NCT07238452
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two procedures for treating atrial fibrillation (AF) in people with heart failure: catheter ablation to restore normal heart rhythm, or a pacemaker plus ablation to control heart rate. About 1056 adults with both conditions will be followed for several years to see which approach reduces death, stroke, and hospital stays. The goal is to find the safest and most effective treatment for this common combination of heart problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,056 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jan 2033
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.
- Ages
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19 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age of 18 years or older on the date of Informed Consent, * Atrial fibrillation, * Left ventricular ejection fraction of 40% or less, measured within 6 months of enrollment, * Receiving stable foundational HF quadruple therapy at maximally tolerated dose, * BNP ≥ 100 pg/mL (NT-proBNP ≥ 400 pg/ml), measured within 1 month of randomisation. Exclusion Criteria: * Anticipated life expectancy less than one year from the consent date, * Continuous atrial fibrillation of \>1 year in duration, * Left atrial anteroposterior diameter \> 6 cm, volume \> 100 mL, or volume index \> 60 mL/m2, * Previous left atrial ablation or left atrial surgery, * The presence of a percutaneous left atrial appendage closure device, * Uncontrolled hypo- or hyperthyroidism, * Subject known to be pregnant or breast-feeding, * Contraindication to oral anticoagulation therapy, * Left atrial myxoma, * Myocardial infarction or percutaneous coronary intervention within 3-months of consent, * History of, or anticipated to undergo heart transplant, ventricular assist device insertion, or mitral or tricuspid valve repair or replacement within 3-months of the consent date.
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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