Clinical trial NCT06988202: Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation
Official title: Comparative Effectiveness of Different Techniques for Repeat Ablation After Failed Initial Ablation for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: atrial fibrillation
irregular heart beat
posterior wall isolation
pulmonary vein isolation
ablation
REPEAT-AF
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2025-05-23
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years on date of consent
* One prior PVI ablation procedure 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 Criteria:

* 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

Primary outcomes:
measure: Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS)
timeFrame: From Baseline to Month 12
Secondary outcomes:
measure: Time to First Atrial Fibrillation Episode Lasting > 30 Seconds
timeFrame: Up to 24 Months Following Randomization
measure: Mean Total Atrial Fibrillation Burden from Serial Holter Recordings
timeFrame: From Randomization through Month 24
measure: Mean Total Number of Cardiovascular Health Care Utilization Events
timeFrame: From Randomization through Month 48
measure: Mean Total Number of Major Clinical Events
timeFrame: From Randomization through Month 48
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Johnathan Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Wojciech Zareba, MD
role: PRINCIPAL_INVESTIGATOR
References: