Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study

Arrhythmia-free survival at 12 months after catheter ablation, excluding the 3-month blanking period, with recurrence defined as any ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds.

trial fibrillation burden measured by continuous implantable loop recorder monitoring, expressed as the percentage of time in AF during predefined assessment windows. AF burden will be evaluated prior to the ablation procedure and again at 12 months post-ablation to compare the effect of the intervention versus standard of care.

Assessment of arrhythmia-free survival at 12 months post-ablation in participants who completed the study without major protocol deviations. Recurrence is defined identically to the primary ITT analysis (ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds after the blanking period). This analysis evaluates the treatment effect under optimal adherence.

Time from the end of the 3-month post-ablation blanking period to the first ILR-detected episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds. This endpoint evaluates the durability of rhythm control beyond the blanking period.

Total number of additional catheter ablation procedures performed per participant after the index ablation in order to restore or maintain sinus rhythm. This endpoint compares the need for redo ablations between the intervention and standard-of-care groups.

Proportion of participants who remain free from symptomatic atrial fibrillation, atrial flutter, or atrial tachycardia without requiring a repeat ablation procedure. Symptomatic episodes are defined by patient-reported symptoms corroborated by rhythm documentation. This endpoint evaluates clinically meaningful rhythm control without the need for additional invasive therapy.

Assessment of atrial fibrillation-related symptom burden and functional impact using the AFEQT and AFSS validated questionnaires. Changes in symptom and quality-of-life scores will be compared between groups to evaluate improvement over time.

Assessment of changes in health-related quality of life using the RAND-36 questionnaire. .A clinically meaningful change is defined as an improvement of approximately 3-5 points in any RAND-36 domain. This endpoint evaluates the impact of the intervention on physical, emotional, and functional well-being over time.

Proportion of participants achieving either ≥10% reduction in baseline body weight or a BMI <27 kg/m². This endpoint assesses the metabolic effect of the intervention compared with standard of care.

Change in systolic and diastolic blood pressure compared with baseline, including the proportion of participants achieving >10% systolic blood pressure reduction. Measurements are performed using standardized clinical procedures to evaluate the intervention's impact on blood pressure control.

Evaluation of changes in fasting glucose and/or HbA1c and/or creatinine and/or NT-proBNP among participants with where these have been obtained through routine clinical care. This endpoint assesses whether the intervention influences glycaemic control and renal function l in patients for whom such measurements are already clinically indicated. No additional study-specific blood tests are performed.

Incidence of procedure-related complications occurring during the catheter ablation or within the post-procedural follow-up period. Events may include vascular complications, pericardial effusion, tamponade, stroke/TIA, transient arrhythmias, anesthesia-related events, or other clinically relevant adverse outcomes, as documented in medical records. This endpoint compares procedural safety between study groups.

Assessment of changes in left ventricular ejection fraction from before to after the ablation procedure, based solely on echocardiograms performed as part of routine clinical care. No study-specific imaging is required; data will be included only for participants who undergo a post-ablation echocardiogram in standard practice. This endpoint evaluates whether the intervention influences cardiac function over time.

Assessment of the proportion of participants with diabetes, renal failure, or heart failure using information from routine clinical care, medical records, and linked registry data. No study-specific testing is performed. This endpoint describes baseline comorbidity burden and identifies new or worsening diagnoses captured through standard care or registries.

Incidence of hospitalizations due to cardiovascular causes, identified through routine clinical records and national or regional registry data. Events may include admissions for arrhythmias, heart failure, acute coronary syndromes, or other cardiovascular conditions. No study-specific assessments are required.

Incidence of hospital admissions for any cause, identified through routine clinical records and national or regional registry data. This endpoint evaluates the broader healthcare impact of the intervention beyond cardiovascular events. No study-specific assessments are required.

Assessment of initiation, discontinuation, or dose changes in antiarrhythmic medications (e.g., class I or III agents, beta-blockers) based on routine clinical records. This endpoint evaluates differences in pharmacologic rhythm control requirements between groups.

Total duration of the catheter ablation procedure, extracted from routine procedural reports. This endpoint evaluates whether pre-ablation metabolic optimization influences procedural complexity.

Total fluoroscopy exposure time and radiation dose recorded during the index ablation procedure, as documented in routine procedural logs. This endpoint assesses potential differences in radiation exposure related to patient characteristics or weight loss.

Assessment of overall healthcare use, including outpatient cardiology visits, emergency department visits, and telephone/remote consultations. Data will be obtained from routine clinical records and linked regional or national healthcare registries. This endpoint evaluates whether the intervention affects healthcare demand and resource use. No study-specific visits or assessments are required.

Exploratory assessment of whether artificial intelligence (AI) analysis of standard 12-lead ECGs can predict arrhythmia recurrence after ablation. ECGs obtained through routine clinical care will be analysed using validated AI algorithms to evaluate associations between ECG-derived features and later recurrence captured by ILR monitoring. No study-specific ECGs are required.