N/A
N=320
Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF
Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT05296824 ↗Enrolled (actual)
320
Serious AEs
3.1%
Results posted
Nov 2025
Primary outcome: Primary: Number of Participants With Recurrent Atrial Fibrillation — 60; 31 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cryoballoon ablation for the treatment of atrial fibrillation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sacramento EP Research
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Recurrent Atrial Fibrillation |
60; 31 | — |
| SECONDARY Number of Participants With Recurrence of All Atrial Arrhythmias |
70; 36 | — |
Summary
Cryoballoon ablation has emerged as a safe and effective strategy for treatment of atrial fibrillation (AF) for which it has recently received a 'first-line' therapy indication by the FDA. Pulmonary vein (PV) isolation (PVI) has been the cornerstone of this procedure achieving freedom from recurrent AF in up to ~80% of patients at 12 months of follow-up. However, the success has been shown to be significantly lower, in the range of 50-60% at 3-5 years of follow-up. Other more recent cryoballoon ablation studies have demonstrated marked improvements in clinical outcomes associated with concomitant PVI and cryoballoon ablation/isolation of the 'PV component' (a region of the left atrial posterior [back] wall lying between the PVs that is anatomically and embryologically related to the PVs), versus PVI alone in patients with persistent AF.
PVI+PWI using cryoballoon ablation has been widely-practiced in patients with paroxysmal AF. However, the acute/long-term safety and efficacy of this approach has not been formally investigated in paroxysmal AF. Given the mechanistic similarities between persistent and paroxysmal AF, the investigators hypothesize that similar benefits associated with PVI+PWI may also be observed in those with paroxysmal AF. Yet, due to the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the acute and long-term efficacy and safety beyond 36 months of follow-up associated with PVI alone versus PVI+PWI using cryoballoon ablation in a large cohort of patients with PAF, performed by a single operator between 1/1/2014 and 8/31/2018 at Mercy General Hospital.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Cryoballoon PVI+PWI
- Cryoballoon PVI alone
- Symptomatic paroxysmal atrial fibrillation
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05296824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.