Could a preventive ablation during flutter treatment ward off future heart trouble?
NCT ID NCT07649603
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether adding a preventive procedure called pulmonary vein isolation (PVI) to the standard ablation for typical atrial flutter can reduce the risk of heart-related hospital visits, stroke, or death. The trial enrolls adults aged 55 and older with an enlarged left atrium and no prior atrial fibrillation. Participants are randomly assigned to receive either standard ablation alone or standard ablation plus PVI, and are followed for several years to compare outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- catheter ablation (CTI ablation plus pulmonary vein isolation)
- What this could lead to
- If successful, this approach could become a standard preventive step during atrial flutter ablation, lowering the chance of future atrial fibrillation and related complications.
- What could go wrong
- This is a mid-stage trial, and the added procedure carries risks like bleeding, infection, or heart rhythm disturbances. It may not reduce events as hoped, and results may not apply to all patients.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 620 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2027
An estimate. Start dates often move.
- Expected to finish
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May 2032
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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55 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.
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: 1. Age ≥ 55 years on date of consent 2. History of typical AFL and plans for a guideline-supported catheter ablation for AFL - including paroxysmal AFL defined as AFL with duration of up to 7 days and persistent AFL as longer than 7 days or if interrupted by cardioversion for clinical reasons and up to 1 year 3. No identifiable AF on any prior ECG within past 1 year 4. CHA2DS2 -VASc ≥ 2 Exclusion Criteria: 1. Inability to undergo or AFL or AF catheter ablation (e.g., presence of a left atrial thrombus) 2. AFL or AF due to reversible cause e.g. hyperthyroid state 3. Contraindication to systemic anticoagulation 4. Prior surgical or percutaneous cardiac ablation procedure any time in the past 5. Prior AFL ablation (e.g. CTI) or PVI ablation any time in the past 6. LV ejection fraction \< 35% 7. Paroxysmal, persistent or longstanding persistent AF 8. Presence of NYHA Class IV congestive heart failure 9. Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date 10. Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent 11. Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures 12. Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date 13. Any medical condition likely to limit survival to \< 1 year 14. Renal failure requiring dialysis at time of consent 15. Pregnancy 16. History of non-compliance to medical therapy 17. Participation in other clinical trials (observational/lead registries are allowed) without approval from the DCC 18. Inability or unwillingness to provide informed consent 19. Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult 20. Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.