Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)

Completed · Not applicable

Conditions studied: Atrial Fibrillation Chronic, Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03057548

Run by

Arash Aryana, MD

People needed

110

Starts

2017-02-24

Expected to finish

2020-05-31

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mercy General Hospital and Dignity Health Heart and Vascular Institute — Sacramento, California, United States
• Heart Center, Japan Red Cross Yokohama-city Bay Hospital — Yokohama, Japan

Full record on ClinicalTrials.gov

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