Arrhythmias & electrophysiology

The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial

JACC Clin ElectrophysiolPublished Secondary analysis of the SHAM-PVI randomised trial

Authors' conclusion

In this secondary analysis of the SHAM-PVI trial, there was a statistically significant relationship observed between AF burden reduction and QoL improvements.

Study context

Population
Patients with symptomatic paroxysmal or persistent atrial fibrillation (AF); AF burden measured continuously via implantable loop recorder
Participants
126 patients
Comparison
Association between AF burden and quality of life (QoL) after cryoballoon pulmonary vein isolation (PVI) or sham procedure
Primary endpoint
Association between AF burden and patient-reported QoL (AFEQT, MAFSI, SF-36)
Methodological detailssham-controlled, double-blind
  • Sham-controlled
  • Double-blind

Primary result

As reported in the abstract

Overall AFEQT score vs reduction in geometric mean AF burden

Reduction in geometric mean AF burden associated with improvement in overall AFEQT score: estimate 0.971 (95% CI 0.962 to 0.981)

P < 0.0001

Further findings

Symptom-specific analysis

Stronger associations of AF burden with palpitations, dizziness, shortness of breath, tiredness, unable to exercise and weakness

Original publication

The Association Between Atrial Fibrillation Burden and Quality of Life: A Substudy of the SHAM-PVI Trial. JACC Clin Electrophysiol. Published 31 October 2025. doi:10.1016/j.jacep.2025.09.013

Summarised from the published abstract; every number is checked against it

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