Trial Outcomes & Findings for Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL) (NCT NCT03057548)

Last Updated: 2025-11-05

Results Overview

The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

One year

Results posted on

2025-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Pulmonary Vein Isolation (PVI) Cryoablation only of Pulmonary Veins or Radiofrequency (RF) ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone. Cryo or RF Ablation only of Pulmonary Veins: Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins OR FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins. Ablation of the Pulmonary Veins alone	PVI & Posterior Left Atrial Ablation Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall or Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW) Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW: Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW OR RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)
Overall Study STARTED	55	55
Overall Study COMPLETED	55	55
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

Baseline characteristics by cohort
Measure	Pulmonary Vein Isolation (PVI) n=55 Participants Cryoablation only of Pulmonary Veins or Radiofrequency ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone. Cryo or RF Ablation only of Pulmonary Veins: Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins OR FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins. Ablation of the Pulmonary Veins alone	PVI & Posterior Left Atrial Ablation n=55 Participants Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall or Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW) Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW: Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW OR RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=55 Participants	0 Participants n=55 Participants	0 Participants n=110 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=55 Participants	26 Participants n=55 Participants	46 Participants n=110 Participants
Age, Categorical >=65 years	35 Participants n=55 Participants	29 Participants n=55 Participants	64 Participants n=110 Participants
Age, Continuous	70 years STANDARD_DEVIATION 9 • n=55 Participants	67 years STANDARD_DEVIATION 8 • n=55 Participants	68.5 years STANDARD_DEVIATION 2.12 • n=110 Participants
Sex: Female, Male Female	22 Participants n=55 Participants	20 Participants n=55 Participants	42 Participants n=110 Participants
Sex: Female, Male Male	33 Participants n=55 Participants	35 Participants n=55 Participants	68 Participants n=110 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	26 participants n=55 Participants	21 participants n=55 Participants	47 participants n=110 Participants
Region of Enrollment Japan	29 participants n=55 Participants	34 participants n=55 Participants	63 participants n=110 Participants
Long-standing persistent atrial fibrillation	17 Participants n=55 Participants	21 Participants n=55 Participants	38 Participants n=110 Participants
Persistent atrial fibrillation	38 Participants n=55 Participants	34 Participants n=55 Participants	72 Participants n=110 Participants

PRIMARY outcome

Timeframe: One year

Population: Study cohort consisted of patients undergoing first-time cryoballoon ablation for symptomatic persistent/long-standing persistent atrial ablation (55 subjects in the PVI isolation arm and 55 subjects in the PVI+PWI arm) were analyzed for freedom from recurrence of atrial fibrillation and all atrial arrhythmias at one-year post-study ablation.

The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation.

Outcome measures

Outcome measures
Measure	PVI & Posterior Left Atrial Ablation n=55 Participants Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall or Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW) Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW: Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW OR RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)	Pulmonary Vein Isolation (PVI) n=55 Participants Cryoablation only of Pulmonary Veins or Radiofrequency ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone. Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins: Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins OR FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins. Ablation of the Pulmonary Veins alone
1-year Freedom From Recurrent Atrial Arrhythmias	14 Participants	25 Participants

SECONDARY outcome

Timeframe: During follow-up, assessed for an estimated total of one year.

The type and frequency of complications following catheter ablation

Outcome measures

Outcome measures
Measure	PVI & Posterior Left Atrial Ablation n=55 Participants Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall or Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW) Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW: Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW OR RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)	Pulmonary Vein Isolation (PVI) n=55 Participants Cryoablation only of Pulmonary Veins or Radiofrequency ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone. Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins: Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins OR FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins. Ablation of the Pulmonary Veins alone
Overall Complication Rate	3 Participants	3 Participants

Adverse Events

PVI Only

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

PVI+PWI

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PVI Only n=55 participants at risk The incidence of adverse events was 5.5% in PVI only group.	PVI+PWI n=55 participants at risk The incidence of adverse events was 5.5% in PVI+PWI group.
Cardiac disorders Cardiac Failure	1.8% 1/55 • Number of events 1 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.	0.00% 0/55 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.
Cardiac disorders Pericarditis	1.8% 1/55 • Number of events 1 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.	0.00% 0/55 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.
Cardiac disorders Pericardial Effusion	1.8% 1/55 • Number of events 1 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.	0.00% 0/55 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.
Cardiac disorders Persistent Phrenic Nerve Palsy	0.00% 0/55 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.	1.8% 1/55 • Number of events 1 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.
Cardiac disorders Bradycardia	0.00% 0/55 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.	1.8% 1/55 • Number of events 1 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.
Vascular disorders Groin Vascular Complication	0.00% 0/55 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.	1.8% 1/55 • Number of events 1 • 1 year following the study ablation procedure. All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.

Other adverse events

Adverse event data not reported

Additional Information

Arash Aryana, MD, PhD

SacEP Research

Phone: 916-453-2684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place