Arrhythmias & electrophysiologyRandomised controlled trial
Efficacy and safety of a novel size-adjustable cryoballoon vs conventional cryoballoon: Results from the CONTRAST-CRYO II randomized clinical trial
- randomized clinical trial
Authors' conclusion
Contrary to our hypothesis, the PNI rate was significantly higher with SACB than with CCB, especially during right inferior PV ablation using the 31-mm balloon. Other safety outcomes and 1-year efficacy were comparable in groups.
Study context
- Population
- Patients undergoing pulmonary vein isolation for atrial fibrillationunderwent ablation according to the allocation · CCB 109 · size-adjustable cryoballoon (SACB) 110
- Participants
- 219 patients
- Comparison
- SACB vs CCB
- SACBn = 110
- CCBn = 109
- Primary endpoint
- Incidence of phrenic nerve injury (PNI)
Primary result
As reported in the abstract
P = 0.02
Secondary outcomes
Cryoballoon PV isolation success
P = 0.42
Single-shot isolation rates
Arrhythmia-free rates · 1 year · log-rank
P = 0.74
- Pulmonary vein (PVs) isolated using the 31-mm balloon in the SACB-group
- 87.3% · 378 of 433 PVs of 110
Procedural parameters
- Largely comparable, except for significantly lower balloon temperatures with SACB
- Procedure and fluoroscopy times were similar
Original publication
Efficacy and safety of a novel size-adjustable cryoballoon vs conventional cryoballoon: Results from the CONTRAST-CRYO II randomized clinical trial. Heart Rhythm. Published 26 May 2026. doi:10.1016/j.hrthm.2026.05.037
Summarised from the published abstract; every number is checked against it