Atrial Fibrillation (AF)
Conditions
Keywords
atrial fibrillation, irregular heart beat, posterior wall isolation, pulmonary vein isolation, ablation, REPEAT-AF
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.
Interventions
PROCEDUREPulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)
A doctor inserts a thin, flexible tube (called a catheter) through a blood vessel, usually in the groin, and guides it to the heart. Once the catheter is in place, the doctor uses pulsed field electroporation, heat (radiofrequency) or cold (cryoablation) to create small scars in the area where the pulmonary veins connect to the left atrium of the heart. These scars block the faulty electrical signals that cause AF, helping the heart maintain a normal rhythm.
PROCEDUREPulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)
PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium.
Sponsors
University of Rochester
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Atrial Fibrillation Episode Lasting > 30 Seconds | Up to 24 Months Following Randomization | A proportion of patients that experience a first recurrence of atrial fibrillation or any atrial tachyarrhythmia lasting more than 30 seconds after repeat ablation (randomization), detected via monitoring. |
| Mean Total Atrial Fibrillation Burden from Serial Holter Recordings | From Randomization through Month 24 | Total cumulative duration (in minutes or hours) of atrial fibrillation or other atrial tachyarrhythmias recorded via serial Holter monitoring during the follow-up period. |
| Mean Total Number of Cardiovascular Health Care Utilization Events | From Randomization through Month 48 | Total number of cardiovascular-related hospital admissions, emergency room visits, and unplanned clinic visits, as recorded in medical records. |
| Mean Total Number of Major Clinical Events | From Randomization through Month 48 | The number of adjudicated major clinical events including decompensated heart failure requiring IV therapy, myocardial infarction, stroke/TIA, major bleeding, syncope, cardiac arrest, device implantation, repeat ablation, thromboembolic events, and serious procedural complications (e.g., atrio-esophageal fistula, tamponade). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohnathan Steinberg, MD
University of Rochester
PRINCIPAL_INVESTIGATORWojciech Zareba, MD
University of Rochester
Outcome results
None listed