Arrhythmias & electrophysiology
Efficacy and safety of a novel size-adjustable cryoballoon vs conventional cryoballoon: Results from the CONTRAST-CRYO II 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.
Summarised from the published abstract; every number is checked against it