NCT06988202

Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation

Enrolling by Invitation
NAAges 18+Interventional
University of Rochester
~630 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS)
Measured over From Baseline to Month 12
Atrial Fibrillation (AF)
1 sites across 1 states
New York1
  • Johnathan Steinberg, MD · PRINCIPAL_INVESTIGATOR · University of Rochester
  • Wojciech Zareba, MD · PRINCIPAL_INVESTIGATOR · University of Rochester

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS)From Baseline to Month 12

    The AFSS is a 19-item self-report instrument measuring atrial fibrillation burden. It includes symptom severity (7 items), frequency/duration (4 items), health care utilization (4 items), and a global well-being visual analog scale. Items are summed into a composite total burden score, ranging from 0 to 100, with higher scores indicating greater symptom burden and healthcare impact.