Arrhythmias & electrophysiology
Concomitant cryoballoon pulmonary vein and posterior wall isolation in persistent atrial fibrillation: Results from the Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) IDE trial
- early termination
Authors' conclusion
Despite early termination rendering the trial statistically underpowered, cryoballoon PVI with "direct" PWI was associated with a trend toward a reduction in AF recurrence at 12 months and a significant reduction in atrial arrhythmia burden vs PVI alone.
Study context
- Population
- Patients with symptomatic, drug-refractory PersAF, refractory/intolerant to ≥1 class I–IV antiarrhythmic drugrandomized, planned enrollment 366
- Participants
- 153 patients
- Exposure
- Cryoballoon pulmonary vein isolation (PVI) with concomitant "direct" posterior wall isolation (PWI) vs PVI alone
- PVI alonen = 77
- PVI + PWIn = 76
- Outcome
- Atrial fibrillation (AF) recurrence
- Follow-up
- 12 months
Methodological detailsrandomized, double blind until randomization after PVI
- Randomized
- Double blind until randomization after PVI
Main finding
As reported in the abstract
P = 0.12
Observational data: associations, not effects.
Further findings
Atrial arrhythmia burden of >0.1% · significantly lower with PVI + PWI
P = 0.02
Need for antiarrhythmic drug therapy · 12 months · lower with PVI + PWI
P = 0.04
Procedure time · longer with PVI + PWI
P < 0.001
| Outcome | PVI alone | PVI + PWI | P value |
|---|---|---|---|
| Acute procedural success | — not stated in the abstract | 98.7% | |
| CryoapplicationsMore with PVI + PWI | 9 ± 4 | 21 ± 6 | P < 0.001 |
| Adjunct radiofrequency ablation required to complete PWI | — not stated in the abstract | 28.9% |
— not stated in the abstract
- Acute procedural success: PVI (all patients) 100%
Study conduct
- Planned enrollment 366; early termination due to funding constraints
- 366
Original publication
Concomitant cryoballoon pulmonary vein and posterior wall isolation in persistent atrial fibrillation: Results from the Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) IDE trial. Heart Rhythm. Published 19 August 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →