N/A
N=110
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
Atrial Fibrillation Chronic · Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03057548 ↗Enrolled (actual)
110
Serious AEs
5.5%
Results posted
Nov 2025
Primary outcome: Primary: 1-year Freedom From Recurrent Atrial Arrhythmias — 25; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins (Procedure); Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arash Aryana, MD
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1-year Freedom From Recurrent Atrial Arrhythmias |
25; 14 | — |
| SECONDARY Overall Complication Rate |
3; 3 | — |
Summary
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone.
The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.
Eligibility Criteria
Inclusion Criteria
- Males and females with an age >18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
- All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
- Patients must be in AF on the day of the procedure
Exclusion Criteria
- Any reversible cause of AF (post-operative, thyroid disorder, etc)
- Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
- Patients with any corrected or uncorrected congenital heart disease
- Patients with a history of hypertrophic cardiomyopathy
- Patients with cardiomyopathy and a left ventricular ejection fraction <35%
- Congestive heart failure, class IV
- Women who are known to be pregnant or have had a positive β-Human Chorionic Gonadotropin (β-HCG) test 7 days prior to procedure
- Patients whose life expectancy is <1 year
- History of left-sided left atrial ablation (catheter or surgically-based)
- Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
Data sourced from ClinicalTrials.gov (NCT03057548). 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.