Arrhythmias & electrophysiology

Impact of alternative efficacy end point definitions on reported outcomes after ablation of paroxysmal atrial fibrillation – Insights from the COMPARE-CRYO study using continuous rhythm monitoring

Heart RhythmPublished prespecified substudy of the COMPARE-CRYO (COMPARison of the PolarX and the Arctic Front CRYOballoon for pulmonary vein isolation) study

Authors' conclusion

Alternative efficacy end point definitions have a significant impact on reported outcomes and health care utilization metrics after AF ablation. These findings are important when considering end point definitions other than the traditional 30 seconds in the design of future AF-ablation trials.

Study context

Population
Patients with paroxysmal atrial fibrillation (AF) undergoing cryoballoon ablation
Participants
201 patients
Comparison
Alternative efficacy end point definitions based on AF-burden, duration or number of episodes vs any atrial arrhythmia lasting ≥30 seconds
Primary endpoint
Any recurrence lasting ≥30 seconds
Follow-up
91-365 days
Methodological detailsimplantable cardiac monitors (ICM), blanking period was 90 days
  • Implantable cardiac monitors (ICM)
  • Blanking period was 90 days

Primary result

As reported in the abstract

Recurrence

89 of 201 patients

44%

Further findings

One-year success rates by arrhythmia duration threshold

≥30 sec
56%
≥24 hrs
97%

One-year success rates by number of episode threshold

≥1 episode
56%
≥100 episodes
98%

One-year success rates by AF-burden threshold

AF-burden >0%
56%
AF-burden >2%
93%

Redo ablations and AF-related hospitalizations

Rates increased for AF-episode durations >1 hour, >6 AF-episodes, and an AF-burden >0.1%
Rates highest for AF-episode durations >24 hours, >33 AF-episodes, and an AF-burden >1%

Original publication

Impact of alternative efficacy end point definitions on reported outcomes after ablation of paroxysmal atrial fibrillation – Insights from the COMPARE-CRYO study using continuous rhythm monitoring. Heart Rhythm. Published 19 September 2025. doi:10.1016/j.hrthm.2025.09.026

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

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