Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

Composite clinical endpoint (all-cause mortality, stroke, serious bleeding, cardiac arrest, or heart failure hospitalization)

First part of the co-primary outcome: Proportion of participants with ≥1 of the following events within 24 months after intervention (visit 2): all-cause death, stroke, serious bleeding, cardiac arrest, or hospitalization for heart failure. Events will be adjudicated per protocol.

Change in RAND-36 General Health score

Second part of the co-primary outcome: Change from baseline in the RAND-36 "General Health" domain score at 24 months after the intervention (visit 2). Scores range 0-100; higher scores indicate better perceived health. Intention-to-treat. Because HRQoL is undefined after death, scores are not imputed for participants who die before the 24-month assessment; instead, deceased participants are assigned the worst rank (worst-rank / composite estimand, ICH E9(R1)) and the primary comparison uses a rank-based test. Missing data other than death are handled under a missing-at-random assumption with pre-specified sensitivity analyses.

Differences of atrial fibrillation and atrial tachycardia burden (ILR-derived) between groups

Differences in percentage of time in atrial fibrillation and atrial tachycardia ("AF/AT burden") measured by continuous monitoring using an implantable loop recorder (ILR) between randomization groups.

Hospitalizations (all-cause and cardiovascular)

Number of hospital admissions, including cardiovascular/AF-related hospitalizations, collected from clinical records.

Serious adverse events and treatment-related complications

Serious adverse events (SAEs) and procedure-/treatment-related complications, including ablation-related and device-related complications, recorded and classified per protocol.

Additional patient-reported outcomes (AF symptoms / disease-specific HRQoL)

Symptom burden and AF-related quality of life assessed using validated questionnaires specified in the protocol (e.g., ASTA and/or AFEQT, as applicable).

Discrimination of an inflammation proteomics-based prediction model for the ACE-AF primary composite outcome

A predefined subgroup of patients included in the County of Stockholm and Östergotland will be analyzed using a targeted inflammation proteomics panel. A prespecified inflammation proteomics score will be computed from the panel. The score combined with baseline clinical covariates will be used to develop a prediction model for time to first occurrence of the ACE-AF primary composite outcome event.

Correlation between change in Epicardial fat and the combined AF/AT burden

Correlation between CT-derived Epicardial fat volume around LA the combined AF/AT burden measured by ILR through follow-up.

Discrimination of a saliva proteomics-based prediction model for the primary composite outcome

In a predefined subgroup providing separate consent, saliva samples will be analyzed using a proteomics platform. A prespecified salivary proteomics score will be used to develop a prediction model for the first occurrence of the study primary composite outcome event from baseline.

Change from baseline in oral health-related quality of life (OHIP-14 total score)

Patient-reported oral health-related quality of life measured using the Swedish version of the Oral Health Impact Profile (OHIP-14). The outcome will be reported as change from baseline in OHIP-14 total score.