Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation
Enrolling by invitation · Not applicable
Conditions studied: Atrial Fibrillation (AF)
In brief
Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. However, this treatment doesn't always work. This study is looking at whether adding an extra step to the usual ablation-specifically treating another area of the heart called the left atrial (LA) posterior wall-can help people feel better overall, compared to just repeating the standard pulmonary vein isolation ablation procedure.
Key facts
- Study ID
- NCT06988202
- Run by
- University of Rochester
- People needed
- 630
- Starts
- 2026-03-18
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years on date of consent
- One prior PVI ablation procedure > 3 months prior for persistent AF
- Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
- Eligible for repeat ablation procedure
- Willingness to comply with all post-procedural follow-up requirements and to sign informed consent
You may not qualify if…
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus)
- Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
- Prior surgical ablation for AF
- Contraindication to systematic anticoagulation
- LA diameter on echocardiogram > 6.0 cms
- LV ejection fraction < 35%
- NYHA class III-IV congestive heart failure
- 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
- Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
- Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
- Prior valve replacement with mechanical prosthesis
- 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
- Stroke within 3 calendar months prior to consent date
- Any medical condition likely to limit survival to < 1 year
- Renal failure requiring dialysis at time of consent
- Pregnancy
- History of non-compliance to medical therapy
- Participation in other clinical trials (observational/lead registries are allowed) without approval from the CCRC
- Inability or unwillingness to provide informed consent
- Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
- Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
Where it is running
- University of Rochester Clinical Cardiovascular Research Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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