Trial Outcomes & Findings for Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF (NCT NCT05296824)
NCT ID: NCT05296824
Last Updated: 2025-11-05
Results Overview
The recurrence of atrial fibrillation following PVI+PWI versus PVI alone using cryoballoon ablation in patients with symptomatic paroxysmal atrial fibrillation during long-term follow-up greater than 3 years.
Recruitment status
COMPLETED
Target enrollment
320 participants
Primary outcome timeframe
56 months
Results posted on
2025-11-05
Participant Flow
Consecutive patients with an age greater than 18 years and symptomatic paroxysmal atrial fibrillation who underwent first-time cryoballoon ablation using either pulmonary vein isolation (PVI) alone or pulmonary vein isolation + Posterior Wall Isolation (PVI+PWI) with at least 36 months of follow-up by a single operator between 1/2014 and 12/2018 at Mercy General Hospital, will be included in this retrospective, non-randomized study.
Participant milestones
| Measure |
Pulmonary Vein Isolation (PVI) Only
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) only
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
Pulmonary Vein Isolation (PVI) With Posterior Wall Isolation (PWI)
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI)
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
160
|
|
Overall Study
COMPLETED
|
160
|
160
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pulmonary Vein Isolation (PVI) Only
n=160 Participants
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) only
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
Pulmonary Vein Isolation (PVI) With Posterior Wall Isolation (PWI)
n=160 Participants
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI)
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=160 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=320 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=160 Participants
|
109 Participants
n=160 Participants
|
200 Participants
n=320 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=160 Participants
|
51 Participants
n=160 Participants
|
120 Participants
n=320 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=160 Participants
|
63 years
STANDARD_DEVIATION 10 • n=160 Participants
|
63 years
STANDARD_DEVIATION 11 • n=320 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=160 Participants
|
61 Participants
n=160 Participants
|
115 Participants
n=320 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=160 Participants
|
99 Participants
n=160 Participants
|
205 Participants
n=320 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
160 participants
n=160 Participants
|
160 participants
n=160 Participants
|
320 participants
n=320 Participants
|
|
Symptomatic paroxysmal atrial fibrillation
|
160 Participants
n=160 Participants
|
160 Participants
n=160 Participants
|
320 Participants
n=320 Participants
|
PRIMARY outcome
Timeframe: 56 monthsThe recurrence of atrial fibrillation following PVI+PWI versus PVI alone using cryoballoon ablation in patients with symptomatic paroxysmal atrial fibrillation during long-term follow-up greater than 3 years.
Outcome measures
| Measure |
Pulmonary Vein Isolation (PVI) Only
n=160 Participants
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) only
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
Pulmonary Vein Isolation (PVI) With Posterior Wall Isolation (PWI)
n=160 Participants
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI)
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
|---|---|---|
|
Number of Participants With Recurrent Atrial Fibrillation
|
60 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 56 monthsThe recurrence of all atrial arrhythmias following PVI+PWI versus PVI alone using cryoballoon ablation in patients with symptomatic paroxysmal atrial fibrillation during long-term follow-up greater than 3 years.
Outcome measures
| Measure |
Pulmonary Vein Isolation (PVI) Only
n=160 Participants
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) only
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
Pulmonary Vein Isolation (PVI) With Posterior Wall Isolation (PWI)
n=160 Participants
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI)
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
|---|---|---|
|
Number of Participants With Recurrence of All Atrial Arrhythmias
|
70 Participants
|
36 Participants
|
Adverse Events
Pulmonary Vein Isolation (PVI) Only
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Pulmonary Vein Isolation (PVI) With Posterior Wall Isolation (PWI)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pulmonary Vein Isolation (PVI) Only
n=160 participants at risk
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) only
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
Pulmonary Vein Isolation (PVI) With Posterior Wall Isolation (PWI)
n=160 participants at risk
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI)
Cryoballoon ablation for the treatment of atrial fibrillation: Cryoballoon ablation for the treatment of atrial fibrillation
|
|---|---|---|
|
Cardiac disorders
Transient Phrenic Nerve Palsy
|
1.9%
3/160 • Number of events 3 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
0.62%
1/160 • Number of events 1 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
|
Cardiac disorders
Persistent Phrenic Nerve Palsy
|
0.62%
1/160 • Number of events 1 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
0.00%
0/160 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
|
Cardiac disorders
Pericardial Effusion
|
1.2%
2/160 • Number of events 2 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
0.62%
1/160 • Number of events 1 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
|
Vascular disorders
Groin Vascular Complication
|
0.62%
1/160 • Number of events 1 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
1.2%
2/160 • Number of events 2 • 36 months
All subjects' electronic medical records were reviewed for any adverse events or serious adverse events for the 36 month time period following the index ablation.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place