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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeat PVI without LA PWI | Other |
| |
| Repeat PVI with LA PWI | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS) | 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. | From Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Atrial Fibrillation Episode Lasting > 30 Seconds | 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. | Up to 24 Months Following Randomization |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Johnathan Steinberg, MD | University of Rochester | Principal Investigator |
| Wojciech Zareba, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Clinical Cardiovascular Research Center | Rochester | New York | 14642 | United States |
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|
| Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) | Procedure | PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium. |
|
| Mean Total Atrial Fibrillation Burden from Serial Holter Recordings |
Total cumulative duration (in minutes or hours) of atrial fibrillation or other atrial tachyarrhythmias recorded via serial Holter monitoring during the follow-up period. |
| From Randomization through Month 24 |
| Mean Total Number of Cardiovascular Health Care Utilization Events | Total number of cardiovascular-related hospital admissions, emergency room visits, and unplanned clinic visits, as recorded in medical records. | From Randomization through Month 48 |
| Mean Total Number of Major Clinical Events | 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). | From Randomization through Month 48 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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