LATAM AF Ablation Registry

BACKGROUND: Despite having a population of approximately 670 million people - representing nearly 8% of the world's population - Latin America has historically been underrepresented in studies evaluating electrophysiology technologies. Furthermore, substantial heterogeneity exists across the region's healthcare systems, largely driven by significant differences in healthcare expenditure between countries. For these reasons, there is a clear need for studies that characterize current practices in catheter ablation for rhythm control across Latin America. This study will not only provide valuable information regarding the effectiveness and safety of pulmonary vein isolation in our region but will also help identify opportunities for educational initiatives aimed at facilitating the adoption of emerging ablation technologies.

METHODS: For the present registry, all centers performing catheter ablation for rhythm control (pulmonary vein isolation [PVI]) in patients with atrial fibrillation will be eligible to participate. Each participating center will be responsible for obtaining the necessary institutional approval to participate in the registry. Patients aged ≥18 years with atrial fibrillation undergoing a first catheter ablation procedure between January 1st, 2027, and January 1st, 2028, will be eligible for inclusion. Patients younger than 18 years of age and those who do not provide informed consent for the collection of research data will be excluded. Because this is a purely observational study, no research-specific interventions will be performed. All procedures correspond to routine clinical care delivered according to the established protocols of each participating electrophysiology service, with adherence to current international standards. All procedures will be performed in the electrophysiology laboratory. The anesthetic strategy (deep sedation or general anesthesia) will be selected according to each institution's standard practice. Similarly, the choice of ablation technique, procedural approach, and equipment will be determined by the treating electrophysiologist in accordance with institutional protocols. As this is a descriptive study, no modifications to routine clinical practice will be introduced. The selection of the energy source (radiofrequency, cryoballoon, or pulsed field ablation), catheter type, and lesion delivery protocol will be at the discretion of the treating physician according to institutional practice. In all cases, pulmonary vein isolation with demonstration of both entrance and exit block will be required as the minimum procedural endpoint. Additional lesion sets (e.g., mitral isthmus line, cavotricuspid isthmus ablation, posterior wall isolation, or other adjunctive lesions) may be performed at the discretion of the treating physician according to routine practice and institutional protocols.

OBJECTIVE: To evaluate the safety (defined as the absence of procedure-related complications) and effectiveness (defined as arrhythmia recurrence during follow-up) of catheter ablation procedures performed for rhythm control in patients with atrial fibrillation. In this descriptive study, safety and effectiveness will be evaluated as the primary endpoints, and additional secondary endpoints will also be assessed.

The primary safety endpoint is the occurrence of any procedure-related complication (acute or late). The primary effectiveness endpoint is arrhythmia recurrence, defined as the documentation of an atrial arrhythmia lasting more than 30 seconds during follow-up after an 8-week blanking period. Secondary endpoints include procedure and fluoroscopy time, reduction in atrial fibrillation burden (in patients with implanted cardiac rhythm devices), reduction in atrial fibrillation-related symptoms, as assessed by the EHRA classification, freedom from antiarrhythmic drug therapy at 1 year.

STATISTICAL ANALYSIS: The data will be analyzed using de-identified databases in which each patient will be assigned a unique study identification number, and all personally identifiable information will be removed. Analyses will be performed by the principal investigator and will include both univariable and bivariable analyses. The primary effectiveness endpoint will be evaluated using Kaplan-Meier survival analysis, and a Cox proportional hazards regression model will be developed, when appropriate, to identify predictors of arrhythmia recurrence. Follow-up time will be defined as the interval between the index ablation procedure and the last clinical follow-up. For the primary safety endpoint, logistic regression analyses will be performed to identify factors associated with procedure-related complications. Acute and late complications will be analyzed separately. Continuous variables will be compared using the Student's t-test or the Wilcoxon rank-sum test, as appropriate according to their distribution. Categorical variables will be compared using the chi-square test. A two-sided p value \<0.05 will be considered statistically significant.